ES2970433T3 - Manufacturing method of intraocular implants with mask and lenses - Google Patents

Abstract

Methods for manufacturing intraocular implants are provided. Intraocular implants can improve a patient's vision, for example by increasing the depth of focus of a patient's eye. In particular, intraocular implants may include a mask having an annular portion with relatively low visible light transmission surrounding a central portion of relatively high transmission, such as a transparent lens or aperture. This construction is adapted to provide an annular mask with a small aperture for light to pass through the retina to increase depth of focus. The intraocular implant may have an optical power for refractive correction. The intraocular implant can be implanted at any location along the optic pathway of the eye. for example, as an implant in the anterior or posterior chamber. (Automatic translation with Google Translate, without legal value)

Description

DESCRIPTION

Manufacturing method of intraocular implants with mask and lenses

Background

Field

This application relates generally to the field of intraocular devices. More particularly, this application relates to intraocular implants and lenses (IOLs), with an aperture to increase the depth of focus (for example, "mask" intraocular lenses) and to manufacturing methods.

Description of the related technique

The human eye functions to provide vision by transmitting and focusing light through a transparent outer portion called the cornea, and further refining the focus of the image by means of a lens on the retina. The quality of the image in focus depends on many factors, including the size and shape of the eye, and the transparency of the cornea and lens.

The optical power of the eye is determined by the optical power of the cornea and lens. In a normal, healthy eye, sharp images of distant objects form on the retina (emmetropia). In many eyes, images of distant objects are formed in front of the retina because the eye is abnormally long or the cornea is abnormally steep (myopia), or they are formed at the back of the retina because the eye is abnormally short or the cornea is abnormally steep. is abnormally flat (farsightedness). The cornea can also be asymmetric or toric, resulting in an uncompensated cylindrical refractive error called corneal astigmatism.

A normally functioning human eye is able to selectively focus on objects either near or far away through a process known as accommodation. Accommodation is achieved by inducing deformation in a lens located inside the eye, which is called the lens. Such deformation is induced by muscles called ciliary muscles. In most individuals, the ability to accommodate decreases with age and these individuals cannot see near without vision correction. If distance vision is also poor, such individuals are usually prescribed bifocal lenses. US 5,210,210 teaches a method for manufacturing a multifocal optic.

Summary

This application relates to intraocular implants for improving a patient's vision, such as by increasing the depth of focus of a patient's eye. The invention relates to a method of manufacturing an intraocular implant as defined in claim 1. The intraocular implants include a mask having an annular portion with relatively low visible light transmission surrounding a central portion of relatively high transmission such like a transparent lens or aperture. This construction is adapted to provide an annular mask with a small opening for light to pass through the retina to increase the depth of focus, sometimes referred to herein as pinhole imaging or pinhole vision correction. holes. The intraocular implant may have an optical power for refraction correction. For example, the mask can be made or combined with intraocular lenses (IOLs). The intraocular implant can be implanted at any location along the optical path in the eye, for example, as an anterior or posterior chamber implant.

IOLs have been developed that provide a safe and effective surgical solution for cataracts. These lenses are surgically implanted after the removal of a natural cataractous lens from the eye, restoring clarity and providing a replacement for the optical power that was removed. In a successful IOL implantation, the patient is typically emmetropic afterward, meaning their eye focuses into the distance. However, conventional IOLs cannot be accommodated to focus at different distances, so the patient typically needs additional correction (e.g., reading glasses) to see close objects clearly. The intraocular implants disclosed herein provide an improvement over currently available IOLs by incorporating a “mask” in the form of an aperture that improves depth of focus.

In certain examples, an intraocular device includes a lens body. The lens body includes a front and back surface. The posterior surface includes a first convex portion, a second concave portion, and a third convex portion. The second concave portion is adjacent to the first convex portion and the third convex portion. The third convex portion is annular and surrounds the second concave portion, and the second concave portion is annular and surrounds the first convex portion. An optical power between the first convex portion and the anterior surface is positive and an optical power between the third convex portion and the anterior surface is positive. The lens body further includes a mask located between the second concave portion and the anterior surface.

In certain examples, a lens body of an intraocular device includes a first surface and a second surface. A first portion of the first surface is convex, a second portion of the first surface is concave, and a third portion of the first surface is convex. The second portion is adjacent to the first portion and the third portion. The lens body further includes a mask positioned to block a substantial portion of optical aberrations that would be created by light passing through the second portion of the first surface.

In certain examples, an intraocular device includes a lens body with a positive optical power. The lens body includes an outer region and a central recessed region. At least a portion of the recessed central region includes a thickness less than at least a portion of the outer region. The lens body further includes a mask coupled with a curved transition between the outer region and the recessed central region.

In certain examples, a method of manufacturing an intraocular device includes providing a lens body with a first surface and a second surface. The method further includes forming a convex surface on a first portion of the first surface, a concave surface on a second portion of the first surface, and a convex surface on a third portion of the first surface. The second portion is adjacent to the first portion and the third portion. The method also includes attaching a mask to the lens body that is positioned to block a substantial portion of light passing through the second portion of the first surface.

The method of manufacturing an intraocular device includes forming a lens body around a mask. The mask includes an aperture and an annular region, and the lens body comprises a first surface and a second surface. In some embodiments, the method further includes forming a convex surface on a first portion of the first surface, a concave surface on a second portion of the first surface, and a convex surface on a third portion of the first surface. The second portion is adjacent to the first portion and the third portion. Forming the lens body around the mask includes locating the mask within the lens body so that, in use, the mask blocks a substantial portion of the light passing through the second portion of the first surface.

In certain examples, an intraocular implant includes an implant body. The implant body may include a pinhole opening in the implant body, and a mask substantially around the pinhole opening. The implant body may further include an outer orifice region substantially outside an outer perimeter of the mask. The outer hole region may include at least one outer hole and at least one connection portion. An outer region of the implant body may be attached to the mask via the at least one connection portion.

In some examples, an intraocular device includes a lens body comprising a surface with a transition zone, the transition zone configured to reduce a thickness of the lens body along an optical axis of the lens body, and a mask. configured to block a substantial portion of optical aberrations that would be created by light passing through the transition zone.

In additional examples, an intraocular device includes a lens body comprising a first surface and a second surface. The first surface comprises a first portion, a second portion and a third portion. An optical axis of the lens body passes through the first portion, and the second portion is between the first portion and the third portion. The intraocular device may also include a mask located between the second surface and the second portion of the first surface. A distance from the first portion adjacent to the second portion to a plane perpendicular to the optical axis and tangent to the second surface may comprise a first distance, and a distance from the third portion adjacent to the second portion to the plane perpendicular to the optical axis and tangent to the second surface may comprise a second distance greater than the first distance.

In other examples, a method of improving a patient's vision includes providing an intraocular device comprising a lens body comprising a surface with a transition zone. The transition zone may be configured to reduce the thickness of the lens body along an optical axis of the lens body, and the intraocular device may further include a mask configured to block a substantial portion of optical aberrations that would be created by light that passes through the transition zone. The method may further include inserting the intraocular device into an intraocular space of an eye.

In certain examples, an intraocular implant includes an implant body comprising an outer surface including a posterior surface and an anterior surface, an opaque mask positioned between the posterior surface and the anterior surface of the implant body. The mask comprises an opening. The intraocular implant may further include a support member coupled to the mask and extending from the mask to the outer surface of the implant body. The support member may extend from the mask to the posterior surface of the implant body. A first portion of the support member adjacent to the mask may have a first cross-sectional area parallel to the mask and a second portion of the support member adjacent to the back surface may have a second cross-sectional area parallel to the mask that is less than the first cross-sectional area. The support member may be configured to be removable from the intraocular implant. The support member may include a plurality of holes characterized in that at least one of the hole size, shape, orientation, and spacing of the plurality of holes varies to reduce the tendency of the holes to produce visible diffraction patterns.

In certain embodiments, a method of manufacturing an intraocular implant includes providing an opaque mask comprising an opening and at least one support element coupled to the mask, positioning the mask within a mold chamber such that the at least one support element support is coupled to the mold chamber so that the mask resists movement, and flowing a lens material into the mold chamber so that at least a portion of the mask is enclosed within the lens material. The method may further include removing at least a portion of the at least one support element after injecting the lens material.

One method of manufacturing an intraocular implant includes coupling an opaque mask comprising an aperture to a surface of a mold chamber, and flowing a lens material into the mold chamber to form an optic coupled to the mask.

In further embodiments, a method of manufacturing an intraocular implant includes removing a portion of a surface of an optic to form an annular cavity around an aperture region, at least partially filling the cavity with an opaque material, removing at least part of the aperture region and a central region of the optics to reduce the thickness of the aperture region of the optics. At least some of the opaque material may remain on the surface of the optic to form an opaque mask.

In another embodiment, a method of manufacturing an intraocular implant includes providing an optic with an annular cavity around an aperture region, at least partially filling the cavity with an opaque material, removing at least part of the aperture region and a central region. of the optic to reduce the thickness of the aperture region of the optic. At least some of the opaque material may remain on the surface of the optic to form an opaque mask.

In even further embodiments, a method of manufacturing an intraocular implant includes placing an opaque mask with an opening within a mold cavity so that the mask is not in physical contact with the mold cavity, and injecting an implant body material into the mold cavity to form an implant body around the mask. For example, the mask can be positioned with magnetic fields or with wires extending from the mask to a frame outside the mold cavity.

In certain examples, an intraocular implant includes an implant body comprising a body material and a mask with an opening located within the implant body. The mask may include a plurality of holes extending between a rear surface and a front surface of the mask. The body material may extend through the plurality of holes of the mask, and the plurality of holes may be characterized in that at least one of the size, shape, orientation and spacing of holes of the plurality of holes varies to reduce the tendency of holes to produce visible diffraction patterns. The plurality of holes may be located at irregular locations. A first plurality of holes may include a first size, shape, or hole spacing and at least another plurality of holes may include a second size, shape, or hole spacing different from the first size, shape, or hole spacing. A first plurality of the holes may include a first hole size, a second plurality of the holes may include a second hole size different from the third hole size, and a third plurality of holes may include a third hole size different from the first hole size and the second hole size.

In one example, an intraocular implant includes an implant body configured to be implanted in a sulcus region of a patient's eye. The implant body may include an opening that is at least partially surrounded by an opaque region that forms a mask and an outer orifice region substantially outside an outer perimeter of the mask. The outer hole region may include at least one outer hole and at least one connecting portion, and the outer hole region may have an incident visible light transmission of at least 90%. The implant body may also include an outer region attached to the mask by the at least one connection portion.

Brief description of the drawings

Figure 1A illustrates a front plan view of an embodiment of an intraocular lens with a central recessed region on the rear surface as described herein.

Figure 1B illustrates a cross-sectional view of the intraocular lens of Figure 1A.

Figure 2A illustrates a front plan view of an embodiment of an intraocular lens with a central region recessed on the anterior surface as described herein.

Figure 2B illustrates a cross-sectional view of the intraocular lens of Figure 2A.

Figure 3A illustrates a front plan view of an embodiment of an intraocular lens with a central recessed region on the posterior surface and the anterior surface as described herein.

Figure 3B illustrates a cross-sectional view of the intraocular lens of Figure 3A.

Figure 4A illustrates a front plan view of an embodiment of an intraocular lens with two transition zones and two masks as described herein.

Figure 4B illustrates a cross-sectional view of the intraocular lens of Figure 4A.

Figure 5A illustrates a front plan view of an embodiment of an intraocular lens with two transition zones and a single mask as described herein.

Figure 5B illustrates a cross-sectional view of the intraocular lens of Figure 5A.

Figure 6A illustrates a front plan view of an embodiment of an intraocular lens with a concave rear surface and a positive optical power as described herein.

Figure 6B illustrates a cross-sectional view of the intraocular lens of Figure 6A.

Figure 7A illustrates a front plan view of an embodiment of an intraocular lens with a concave rear surface and a negative optical power as described herein.

Figure 7B illustrates a cross-sectional view of the intraocular lens of Figure 7A.

Figure 8 is a schematic cross-sectional representation of light passing through the intraocular lens of Figure 2B.

Figure 9 is a schematic representation of light from a distant object transmitted through an eye having an embodiment of an intraocular lens that is in the capsular bag.

Figure 10A illustrates a top view of a conventional intraocular lens.

Figure 10B illustrates a cross-sectional view of the conventional intraocular lens of Figure 10A.

Figure 11A is a perspective view of one embodiment of a mask.

Figure 11B is a perspective view of one embodiment of a substantially planar mask.

Figure 12 is a side view of an embodiment of a mask having a variable thickness.

Figure 13 is a side view of another embodiment of a mask having a variable thickness.

Figure 14 is a side view of an embodiment of a mask with a material for providing opacity to the mask.

Figure 15 is an enlarged, schematic view of an embodiment of a mask that includes a particulate structure adapted to selectively control the transmission of light through the mask in a low light environment.

Figure 16 is a view of the mask of Figure 15 in a bright light environment.

Figure 17 is another embodiment of a mask that includes connectors for securing the mask within the eye.

Figure 18A is a top view of another embodiment of a mask configured to increase the depth of focus.

Figure 18B is an enlarged view of a portion of the view of Figure 18A.

Figure 19 is a cross-sectional view of the mask of Figure 18B taken along section plane 19-19.

Figure 20A is a graphical representation of a hole arrangement of a plurality of holes that may be formed on the mask of Figure 18A.

Figure 20B is a graphical representation of another hole arrangement of a plurality of holes that may be formed on the mask of Figure 18A.

Figure 20C is a graphical representation of another orifice arrangement of a plurality of orifices that may be formed on the mask of Figure 18A.

Figure 21A is an enlarged view similar to that of Figure 18A showing a variation of a mask having a non-uniform size.

Figure 21B is an enlarged view similar to that of Figure 18A showing a variation of a mask having a non-uniform facet orientation.

Figure 22 is a top view of another embodiment of a mask having an orifice region and a peripheral region.

Figure 23 is a flow chart illustrating a method of manufacturing a masked intraocular implant from a mask comprising a highly fluorinated polymer and an opacifying agent.

Figure 24A is a top plan view of one embodiment of a mask configured to increase the depth of focus as described herein.

Figure 24B is a front plan view of one embodiment of a mask configured to increase the depth of focus as described herein.

Figure 24C is a front plan view of one embodiment of a mask configured to increase the depth of focus as described herein.

Figure 24D is a front plan view of one embodiment of a mask configured to increase the depth of focus as described herein.

Figure 25A is a cross-sectional view of an embodiment of an intraocular implant with a mask attached to the anterior surface of a transition zone as described herein.

Figure 25B is a cross-sectional view of one embodiment of an intraocular implant with a mask attached to the posterior surface as described herein.

Figure 25C is a cross-sectional view of an embodiment of an intraocular implant with a mask embedded within the implant body approximately halfway between the posterior and anterior surfaces as described herein.

Figure 25D is a cross-sectional view of an embodiment of an intraocular implant with a mask embedded within the implant body that is closer to the anterior surface than the posterior surface as described herein.

Figure 25E is a cross-sectional view of an embodiment of an intraocular implant with a mask embedded within the implant body that is closer to the posterior surface than the anterior surface as described herein.

Figure 25F is a cross-sectional view of an embodiment of an intraocular implant with a mask embedded within the implant body and within close proximity of the anterior surface of a transition zone as described herein.

Figure 25G is a cross-sectional embodiment of an intraocular implant with a mask extending between the anterior and posterior surfaces as described herein.

Figure 26A is a front plan view of an embodiment of an intraocular implant with support elements extending from the mask to a peripheral surface of the implant body as described herein.

Figure 26B is a cross-sectional view of an embodiment of an intraocular implant with support elements extending from the mask to the posterior surface of the implant body as described herein.

Figure 26C is a cross-sectional view of an embodiment of an intraocular implant with a mask integrated with the support elements as described herein.

Figure 27A is a cross-sectional view of one embodiment of an intraocular implant with flanges extending from the mask to the posterior surface of the implant body as described herein.

Figure 27B is a cross-sectional view of the intraocular implant of Figure 27A where a portion of the tabs has been removed.

Figure 28A is a front plan view of an embodiment of an intraocular implant with a support member as described herein.

Figure 28B is a cross-sectional view of the intraocular implant of Figure 28A.

Figure 29A is a front plan view of an embodiment of an intraocular implant with a different optical power than the intraocular implant of Figure 27A.

Figure 29B is a cross-sectional view of the intraocular implant of Figure 29A.

Figure 30A is a front plan view of an embodiment of an intraocular lens with a mask extending radially beyond the outer periphery of the transition zone as described herein.

Figure 30B is a cross-sectional view of the intraocular implant of Figure 30A.

Figure 31A is a front plan view of another embodiment of an intraocular implant with a support member as described herein.

Figure 31B is a cross-sectional view of the intraocular implant of Figure 31A.

Figure 32A is a front plan view of another embodiment of an intraocular implant with a mask that extends radially beyond the outer periphery of the transition zone as described herein.

Figure 32B is a cross-sectional view of the intraocular implant of Figure 32A.

Figure 33A is a front plan view of a further embodiment of an intraocular implant with a support member as described herein.

Figure 33B is a cross-sectional view of the intraocular implant of Figure 33A.

Figure 34A is a front plan view of a further embodiment of an intraocular implant with a mask that extends radially beyond the outer periphery of the transition zone as described herein.

Figure 34B is a cross-sectional view of the intraocular implant of Figure 34A.

Figure 35A is a front plan view of an embodiment of an intraocular implant with a support member coupled with a haptic as described herein.

Figure 35B is a cross-sectional view of the intraocular implant of Figure 35A.

Figure 36A is a front plan view of another embodiment of an intraocular implant with a support member coupled with a haptic as described herein.

Figure 36B is a cross-sectional view of the intraocular implant of Figure 36A.

Figure 37A is a cross-sectional view of an intraocular implant.

Figure 37B is a cross-sectional view of the intraocular implant of Figure 37A with a cavity formed in the implant body.

Figure 37C is a cross section of the intraocular implant of Figure 37B with the cavity at least partially filled with an opaque material.

Figure 37D is a cross-sectional view of the intraocular implant of Figure 37C with a portion of the opaque material and the central region removed.

Figure 38A is a cross-sectional view of an intraocular implant.

Figure 38B is a cross-sectional view of the intraocular implant of Figure 38A with a cavity formed in the implant body.

Figure 38C is a cross-sectional view of the intraocular implant of Figure 38B with a mask located within the cavity.

Figure 38D is a cross-sectional view of the intraocular implant of Figure 38C with the cavity at least partially filled with an implant body material.

Figure 38E is a cross-sectional view of the intraocular implant of Figure 38D with a portion of the implant body removed.

Figure 39A is a cross-sectional view of an intraocular implant.

Figure 39B is a cross-sectional view of the intraocular implant of Figure 38A with a cavity formed in the implant body.

Figure 39C is a cross-sectional view of the intraocular implant of Figure 39B with the cavity at least partially filled with an opaque material.

Figure 39D is a cross-sectional view of the intraocular implant of Figure 39C with a portion of the opaque material and the central region removed.

Figure 40 is a schematic of one embodiment of a mask positioning system for positioning a mask within a mold cavity as described herein.

Figure 41 is an illustration of one embodiment of a mask positioning apparatus that includes wires attached to a mask and a frame as described herein.

Figure 42 is a side view of an embodiment of a levitated mask with a magnetic field as described herein.

Figure 43A is a top view of an embodiment of a magnetic field levitated mask as described herein.

Figure 43B is a top view of another embodiment of a mask levitated above magnetic fields as described herein.

Figure 44 is a schematic of one embodiment of using electrostatic levitation to position a mask as described herein.

Figure 45 is a top view of an embodiment of a bistable display that is capable of forming a mask as described herein.

Figure 46 is a top perspective view of an embodiment of a masked intraocular implant configured to increase the depth of focus described herein.

Figure 47 is a top plan view of the intraocular implant of Figure 46.

Figure 48A is a side elevation view of one embodiment of an intraocular implant with a mask through the intraocular implant of Figure 46.

Figure 48B is a side elevation view of an embodiment of an intraocular implant with a mask on the posterior surface of the intraocular implant.

Figure 48C is a side elevation view of an embodiment of an intraocular implant with a mask on the anterior surface of the intraocular implant.

Figure 48D is a side elevational view of an embodiment of an intraocular implant with a mask located midway between the posterior and anterior surfaces of the intraocular implant.

Figure 48E is a side elevational view of an embodiment of an intraocular implant with a mask located between the posterior surface and a position midway between the posterior and anterior surfaces of the intraocular implant.

Figure 48F is a side elevational view of an embodiment of an intraocular implant with a mask located between the anterior surface and a position midway between the posterior and anterior surfaces of the intraocular implant.

Figure 49A is a top perspective view of one embodiment of an intraocular implant with five external holes described herein.

Figure 49B is a top plan view of the intraocular implant of Figure 56A.

Figure 49C is a side elevation view of the intraocular implant of Figure 56A.

Figure 50A is a top perspective view of an embodiment of an intraocular implant with a different haptic than the intraocular implant of Figure 56A described herein.

Figure 50B is a top plan view of the intraocular implant of Figure 57A.

Figure 50C is a side elevation view of the intraocular implant of Figure 57A.

Figure 51A is a top plan view of one embodiment of an intraocular implant with a single external hole described herein.

Figure 51B is a top plan view of an embodiment of an intraocular implant with two external holes described herein.

Figure 51C is a top plan view of an embodiment of an intraocular implant with three external holes described herein.

Figure 51D is a top plan view of an embodiment of an intraocular implant with four external holes described herein.

Figure 51E is a top plan view of an embodiment of an intraocular implant with six external holes described herein.

Figure 52 is a top plan view of an embodiment of an intraocular implant with an outer hole region extending outward near the periphery of the implant body described herein. Figure 53A is a top plan view of an embodiment of an intraocular implant with an outer hole region that extends outward further from the opening in one direction than another described herein.

Figure 53B is a top plan view of an embodiment of an intraocular implant with non-uniform external holes described herein.

Figure 54 is a top plan view of an embodiment of an intraocular implant with an outer hole region partially surrounding the opening described herein.

Figure 55 is a top plan view of an embodiment of an intraocular implant with a centrally located opening and an offset outer hole region described herein.

Figure 56 is a top plan view of an embodiment of an intraocular implant with a centrally located outer hole region and an offset opening described herein.

Figure 57 is a top plan view of an embodiment of an intraocular implant in which the mask includes light transmission holes described herein.

Figure 58 is a top plan view of an embodiment of an intraocular implant with light transmission holes that gradually increase in size radially outward from the opening.

Figure 59 is a graph of visual acuity versus defocus comparing two typical multifocal IOLs and one embodiment of an ophthalmic device with an aperture described herein.

Detailed description

This application relates to intraocular implants and methods of implanting intraocular implants. The natural lens of an eye is often replaced with an intraocular lens when the natural lens has become clouded by a cataract. An intraocular lens can also be implanted in the eye to correct other refractive errors without removing the natural lens. Intraocular implants of preferred embodiments include a mask adapted to provide a small opening for light to pass through the retina to increase the depth of focus, sometimes referred to herein as pinhole imaging or pinpoint correction. vision of small holes. Intraocular implants can be implanted in the anterior chamber or the posterior chamber of the eye. In the posterior chamber, implants can be fixed in the ciliary sulcus, in the capsular bag, or anywhere an intraocular implant is fixed. In some embodiments discussed below, the intraocular lenses have a reduced thickness in a central region compared to conventional intraocular lenses. The reduced thickness in the central region may help improve implantation of the intraocular lens. In additional embodiments discussed below, the intraocular implants may have an outer hole region (e.g., perforated region) to improve a patient's low-light vision.

I. Intraocular implants with reduced thickness

Several alternatives to fixed-focus IOLs have been developed, including multifocal IOLs and accommodating IOLs that attempt to provide the ability to see clearly both at distance and near. Multifocal IOLs provide good acuity at both distance and near, but these lenses typically do not perform well at intermediate distances and are associated with glare, halos, and night vision difficulties associated with the presence of out-of-focus light. Accommodating IOLs of various designs have also been developed, but so far none have been able to replicate the function of the natural lens. Vorosmarthy has described IOLs with apertures (US Patent No. 4,976,732). These devices, however, do not attempt to shift focus from far to near, but rather simply attempt to reduce image blur to a level at which a presbyopic emmetropic person can read. Notably, Vorosmarthy did not address the problem of reducing the thickness of a mask IOL for application in small-incision surgery.

Some embodiments of the present application provide a masked IOL with thinner optics than is known in the art. The advantage of thinner optics is that the IOL can be inserted through a smaller incision in the eye. Since corneal incisions tend to distort the cornea and impair vision, reducing the size of the incision will improve the quality of vision. The optics are made thinner by means similar to a Fresnel lens, where alternating concentric zones provide focusing power and height steps. Although the thickness reduction possible with a Fresnel lens is significant, the height steps are optically inappropriate for clinical application. They do not focus light onto an image in the fovea, but instead scatter the light, which leads to dysphotopsias (streaks, shadows, halos, etc.) in the patient's vision. By combining Fresnel-type height steps with a mask that blocks light from passing through the steps and allows light to pass only through the focusing surfaces, the dysphotopsias associated with a common Fresnel lens can be eliminated, obtaining the benefit of reduced thickness without introducing unwanted optical effects.

Generally, intraocular implants are implanted in the eye by rolling an intraocular implant and inserting the rolled intraocular implant into a tube. The tube is inserted into an incision in the eye, and the intraocular implant is ejected from the tube and deployed into the eye. Intraocular implants may be implanted within the lens capsule after extraction of the natural lens, or in the anterior chamber, posterior chamber, and may be attached to or attached to the ciliary sulcus (sometimes referred to herein as “fixed in the sulcus”). "). Depending on the location of the intraocular implant within the eye, the dimensions of the intraocular implant can be adjusted. including, but not limited to, the opening of the mask. By reducing the thickness of the central region of the intraocular lens, the intraocular lens can be rolled more tightly and inserted into a smaller tube. A smaller incision may be made in the eye if a smaller tube is used. The result is a less invasive procedure with a faster recovery time for the patient. Additionally, compared to a conventional posterior chamber phakic IOL, a reduced thickness lens that is fixed in the ciliary sulcus will allow more space between the posterior surface of the IOL and the surface of the natural lens, thus reducing the potential for contact. between these surfaces.

In certain embodiments, an intraocular lens 100 includes a lens body 102 with an optical power to refract light and correct refractive errors of the eye. Certain embodiments are illustrated in Figures 1-10. The intraocular lens 100 may include one or more haptics 104 to prevent the intraocular lens 100 from moving or rotating within the eye. As used herein, the term “haptic” is intended to be a broad term encompassing struts and other mechanical structures that can be applied against an inner surface of an eye and mounted on a lens structure to securely position a lens. lens in an optical path of an eye. The haptics 104 can have a variety of shapes and sizes depending on the location where the intraocular lens 100 is implanted in the eye. The haptics illustrated in Figures 1-10 can be interchanged with any variety of haptics. For example, the haptics illustrated in Figures 1-10 can be combined with the intraocular lens illustrated in Figures 1-10. Haptics can be C-shaped, J-shaped, plate-shaped, or any other design. An intraocular implant described herein may have two, three, four or more haptics. Haptics can be of open or closed configuration and can be flat, angled or stepped dome. Examples of haptics are disclosed in US Patents 4,634,442; 5,192,319; 6,106,553; 6,228,115; Re. 34,251; and US Patent Application Publication 2003/0199978.

In certain embodiments, the lens body 102 includes a rear surface 110 and a front surface 112, as illustrated in Figures 1A-B. The lens body 102 includes a first portion 116 (e.g., inner portion or central region), a second portion 114 (e.g., transition zone), and a third portion 118 (e.g., outer portion or region) on the surface. rear 110. The second portion 114 may be between and/or adjacent to the first portion 116 and the third portion 118. The second portion 114 may substantially surround the first portion 116, and the third portion 118 may substantially surround the second portion 114. In certain embodiments, the first portion 116 is substantially circular, and the second portion 114 and the third portion 118 are substantially annular. The first portion 116 and the third portion 118 may refract light or have optical power to improve a patient's vision. The second portion 114 has one or more facets, grooves, ridges, valleys, depressions, contours, surface curvatures, etc. to make the first portion 116 closer to the front surface 112 than if the rear surface 110 did not have the second portion 114. The second portion 114 can also be described as a "transition zone" between the first portion 116 and the third portion 118. For example, the transition zone of the second portion 114 may slope toward the front surface 112 from the third portion 118 to the first portion 116. In certain embodiments, the transition zone of the second portion 114 includes a surface substantially perpendicular to the anterior surface 112. The transition zones are like those incorporated in a Fresnel lens. They allow the lens barrel to be made thinner than would be required in a conventional lens design. However, as with Fresnel lenses, the transition zones introduce optical aberrations that would not be clinically acceptable in intraocular lenses.

The intraocular lens 100 may include a mask 108 that may be positioned to block a substantial portion of the light that would pass through the transition zone of the second portion 114 of the posterior surface 110. “Blocked,” as used in this context , includes preventing at least a portion of light from passing through the mask, as well as preventing substantially all of the light from passing through the mask. If the mask 108 did not block the light rays that would pass through the second portion 114, aberrations would occur since the refraction of light (e.g., optical power, etc.) in the second portion 114 is normally different than that in the first portion 116 and the third portion 118.

In certain embodiments, the first portion 116 is convex, the second portion 114 is concave, and the third portion 118 is convex. In certain embodiments, the first portion 116 and the third portion 118 have a positive or convergent optical power and the second portion 114 has a negative or divergent optical power. The second portion 114 may have curvature or no curvature in a direction extending radially from the first portion 116 to the third portion 118. For example, the second portion 114 may have a positive or negative curvature (e.g., convex or concave). in a direction extending radially from the first portion 116 to the third portion 118. Additionally, the second portion 114 may form a closed loop and have a surface similar to a frusto-conical outer surface.

In certain embodiments, the first portion 116 is within a central region 132 of the lens body 102. The central region 132 may be recessed within the lens body 102. In certain embodiments, the third portion 118 is within an outer region 130. of the lens body 102. In certain embodiments, an outer perimeter of the first portion 116 is surrounded and/or enclosed by an inner perimeter of the second portion 114. In certain embodiments, an outer perimeter of the second portion 114 is surrounded and/or or enclosed by an interior perimeter of the third portion 118. In certain embodiments, the maximum thickness of the lens body 102 in the region of the first portion 116 is less than the maximum thickness of the lens body 102 in the region of the second portion 114.

In certain embodiments, a lens body 202 includes a first portion 222, a second portion 220, and a third portion 224 on the front surface 212, as illustrated in Figures 2A-B. The first portion 222, the second portion 220 and the third portion 224 on the front surface 212 may have characteristics similar to those described above for the first portion 116, the second portion 114 and the third portion 118 on the front surface 112. The lens intraocular 200 may include a mask 208 that is positioned to block a substantial portion of light passing through the second portion 220 of the anterior surface 212.

In certain embodiments, both a front surface 312 and a rear surface 310 have a first portion 316, 322, a second portion 314, 320, and a third portion 318, 324, as illustrated in Figures 3A-B. A mask 308 may be positioned so that a substantial portion of the light passing through the second portion 320 of the front surface 312 and the light that would pass through the second portion 314 of the rear surface 310 will be blocked by the mask. 308.

In certain embodiments, the mask is engaged with the second portion, which is concave. For example, the mask may be located adjacent to the second portion. In certain embodiments, the mask is attached to the posterior surface, the anterior surface, or the posterior and anterior surfaces. In certain embodiments, the mask is within the lens body or between the back surface and the front surface. The radial width or area of the mask may be approximately the same as the radial width or area of the second portion. In certain embodiments, the mask may extend at least partially into the area of the first portion and/or the third portion of the lens body. As the mask extends into the first portion and/or the third portion, the mask can block light that enters at large angles outside the optical central axis of the lens body and can then pass through the second portion.

Illustrated in Figures 4A-B, an intraocular lens 400 may further include a fourth portion 420b and a fifth portion 424b on the anterior surface 412 and/or the posterior surface 410. The fourth portion 420b is adjacent to the third portion 424a and may substantially surround the third portion 424a. The fifth portion 424b is adjacent to the fourth portion 420b and may substantially surround the fourth portion 420b. The fourth portion 420b may have characteristics similar to those described above for the second portion 420a, and the fifth portion 424b may have characteristics similar to those described above for the third portion 424a. The intraocular lens 400 may include a first mask 408a that is positioned to block a substantial portion of light passing through the second portion 420a of the anterior surface 412, and a second mask 408b that is positioned to block a substantial portion of light. passing through the fourth portion 420b of the anterior surface 412. It should be understood that additional pairs of portions may be additionally included with a mask such as the fourth portion 420b, the fifth portion 424b and the second mask 408b in an intraocular lens.

Figures 5A-B illustrate an intraocular lens 500 similar to the intraocular lens 400 illustrated in Figures 4A-B. Instead of the intraocular lens 400 having a first mask 408a and a second mask 408b, the intraocular lens 500 has a single mask 508 with a plurality of light transmission holes that allow at least partial light transmission through the lens. mask 508. The light transmission holes may be configured to substantially not allow light to pass through the second portion 520a and the fourth portion 520b to pass through the mask 508, but allow at least some light to pass. through the third portion 524a to pass through the mask 508. For example, a middle annular region of the mask may have a plurality of holes to allow at least some light to pass through the mask, and a Inner annular region and an outer annular region may have substantially no holes. Light transmission structures or holes are further discussed in the sections below and may be applied to the embodiments discussed herein.

The variety of intraocular lenses described herein are designed to fit the vision correction needs of particular patients. For example, for patients with relatively small pupils, dim light may present more of a vision problem than for patients with larger pupils. For patients with smaller pupils, a mask with more light transmission and/or a smaller outer diameter will increase the amount of light reaching the retina and may improve vision in dim light situations. Conversely, for patients with larger pupils, less light transmission and/or a larger outer diameter mask can improve low-contrast near vision and block more out-of-focus light. The masked IOLs described herein provide the surgeon with flexibility to prescribe the appropriate combination of masked IOL features for particular patients.

Figures 6-7 illustrate additional embodiments of intraocular lenses 600, 700. The posterior surface and the anterior surface of an intraocular lens may have a variety of curvatures. For example, the posterior surface and/or the anterior surface may be concave or convex. Figures 6A-B illustrate an intraocular lens 600 with a concave posterior surface 610 with an anterior surface 612 to create a positive optical power lens. Figures 7A-B illustrate an intraocular lens 700 with a concave posterior surface 710 with an anterior surface 712 to create a negative optical power lens. Both intraocular lenses 600, 700 have a second portion 620, 720 to reduce the overall thickness of the intraocular lenses 600, 700. Both intraocular lenses 600, 700 may also include a mask 608, 708 to block light passing through the second portion 620, 720. For negative power intraocular lenses, such as the intraocular lens 700 of Figure 7, the thickness of the central region 732 of the lens body 702 may not be reduced by the second portion 720. However, the thickness of the outer region 730 of the lens body 702 may be reduced by the second portion 720 (e.g., transition zone). Advantageously, if an intraocular lens has a positive optical power or a negative optical power, the thickness of at least a portion of the lens body can be reduced by causing the lens body to include a second portion.

Tables I and II illustrate examples of intraocular lenses with reduced lens body thicknesses. The column marked “Reduced” corresponds to an intraocular lens with a second portion (e.g., transition zone), and the column marked “Original” corresponds to an intraocular lens without a second portion. The optical diameter is the diameter of the outermost portion of the lens body with an optical power. The percentage reduction in core thickness indicated in Tables I and II may be approximately proportional to the reduction in the potential coiled diameter of a reduced thickness IOL. Therefore, the percentage reduction in core thickness indicated in Tables I and II may also be approximately proportional to the reduction in the size of the incision that can be used during IOL implantation in a patient. An IOL is rolled and inserted into a tube, and the tube is inserted into the incision. The IOL can then be deployed into the intraocular space of the eye. The IOL is often rolled as tightly as possible so that open space (e.g., gaps) is minimized in a cross-section of the tube at a location where the implant body has the greatest cross-sectional area which is generally parallel to the axis. optics of the implant body. Therefore, the cross-sectional area of the tube is greater than or equal to the largest cross-sectional area of the implant body which is generally parallel to the optical axis of the implant body. For example, a 36% reduction in the cross-sectional area of the implant body could reduce the cross-sectional area of the tube by 36% or could reduce the diameter of the tube by approximately 20%. A minimum incision length is generally half the circumference of the tube. Therefore, a 36% reduction in cross-sectional area of the implant body can result in an approximately 20% reduction in incision length. For example, a 1.8 mm incision could be reduced to approximately 1.44 mm. A smaller incision is beneficial because it prevents postoperative astigmatism.

Table I. Examples of reduced thickness IOLs with positive optical power.

Table II. Examples of reduced thickness IOLs with negative optical power.

Figure 8 illustrates the operation of the intraocular lens 200 of Figures 2A-B. In use, light enters the anterior surface 212, passes through the lens body 202, and exits through the posterior surface 210 of the intraocular lens 200. The mask 208 is located such that the mask 208 blocks a substantial portion of light rays 850 passing through the second portion 220 of the front surface 212, as illustrated in Figure 8. If the mask 208 did not block the light rays 850 passing through the second portion 220, would produce aberrations. For example, if the curvature of the second portion 220 is configured to provide negative or divergent optical power, light rays 860 passing through this region would diverge and not be focused, as illustrated in Figure 8. The rays of light 850 passing through the first portion 222 and/or the third portion 224 would have a positive or converging optical power. If the first portion 222 and the third portion 224 have a similar curvature or optical power, the light rays 450 entering the front surface 212 and passing through the first portion 222 and/or the third portion 224 would converge at a point common 870 after passing through the posterior surface 210, as illustrated in Figure 8. Figure 9A illustrates an intraocular lens 200 implanted within the capsular bag 954 of an eye 952. Parallel light rays 950 passing through through the intraocular lens 200 they converge on the retina 956.

The lens body 202 may include one or more materials. In certain embodiments, lens body 202 includes two or more materials. For example, the first portion 222 and the third portion 224 may include different materials. If the materials selected for the first portion 222 and the third portion 224 have different refractive indices, the curvature of the first portion 222 and the third portion 224 may be different to obtain similar optical power (e.g., dioptric power) for both. portions.

Generally, the optical power of an intraocular lens is selected to focus on distant objects. A natural lens can be deformed to change the focal length for distance and near vision. Conventional artificial intraocular lenses generally cannot change the focal length. For example, in an eye with presbyopia or where an artificial intraocular lens has an optical power for a greater distance, the light rays entering the eye and passing through the cornea and the natural lens or artificial intraocular lens converge at one point. behind or in front of the retina and do not converge at a point on the retina. The light rays hit the retina over a larger area than if the light rays converged at a point on the retina. The patient experiences this as blurred vision, particularly for close-up objects such as when reading. For such conditions, the mask 208 of the intraocular lens 200 may be configured with an aperture so that only a subset of the light rays, e.g., a central portion, are transmitted to the retina. The mask 208 with an aperture can improve the depth of focus of a human eye. For example, the opening may be a small hole opening. The mask 208 blocks a portion of the exterior light rays, resulting in more focused light rays. The mask 208 may include an annular region surrounding an opening. The opening may be located substantially centrally on the mask. For example, the aperture may be located about a central axis of the mask, also called the optical axis of the mask. The opening of the mask can be circular or any other shape.

The mask 208 may be located in a variety of locations on or on the intraocular lens 200. The mask 208 may be located across the lens body 202. The mask 208 may be positioned on the anterior or posterior surface of the lens body 202. In In certain embodiments, the mask 208 is embedded within the lens body. For example, the mask 208 may be located substantially on the line halfway between the posterior and anterior surfaces of the lens body 202. In certain embodiments, the mask 208 is located between the line halfway and the posterior surface of the lens body 202. lens 202. Certain embodiments include the mask 208 being located halfway, one third or two thirds between the halfway line and the rear surface of the lens body 202. In certain other embodiments, the mask 208 is located between the line halfway and the anterior surface of the lens body 202. Certain embodiments include the mask 208 being located halfway, one third or two thirds between the halfway line and the anterior surface of the lens body 202. If the area transition zone is on the anterior surface of the implant body and the mask is positioned to be on or near the surface of the transition zone on the anterior surface, the mask may not extend beyond the transition zone since the Light, even at large angles from the optical axis incident or passing through the surface of the transition zone, would be blocked by the mask.

In certain embodiments, the mask 208 of an intraocular lens 200 has an opening where the mask blocks a portion of light to improve visualization of nearby objects, similar to a mask previously discussed. Advantageously, the mask 208 may provide an opening and may block a portion of light that may not converge on the retina 956 and also block light passing through the second portion 220, creating aberrations, as described above. In certain embodiments, the mask opening 208 has a diameter of about 1 to 2 mm. In certain embodiments, the mask 208 has an outer perimeter with a diameter of approximately 3 to 5 mm.

In certain embodiments, the third portion 224 of the intraocular lens 200 may improve low light vision. As the pupil of the eye enlarges, light rays will eventually enter and pass through the third portion 224 of the intraocular lens 200. As illustrated in Figure 9, if the pupil 958 of the eye 952 is large enough As for light rays 950 to pass through the third portion 224 of the intraocular lens 200, additional light rays 950 will impinge on the retina. As discussed above, the intraocular lens 200 may have an optical power to correct vision of distant objects so that light rays from a distant object are focused on a point on the retina. Nearby objects during low light conditions may result in an out of focus image if the intraocular lens 200 has an optical power to view distant objects.

The mask 208 may have different degrees of opacity. For example, mask 208 may block substantially all visible light or may block a portion of visible light. The opacity of the mask 208 may also vary in different regions of the mask 208. In certain embodiments, the opacity of the outer edge and/or the inner edge of the mask 208 is less than that of the central region of the mask 208. opacity in different regions can make an abrupt transition or have a gradient transition. Additional examples of opacity transitions can be found in US Patents 5,662,706, 5,905,561 and 5,965,330.

A conventional intraocular lens 1000 is illustrated in Figures 10A-B. By having a recessed portion on the posterior surface 310 (created by the second portions 314) and/or the anterior surface 312 (created by the second portion 320) of the lens body 302, the maximum thickness of the intraocular lens 300 is reduced by comparison with a conventional lens body 1002 without such portions, as shown in Figure 10B. The cross-sectional thickness of the lens body 1002 generally depends on the optical power of the intraocular lens 1000 and the material of the lens body 1002. In particular, the central region of the lens body 1002 is generally the thickest section of the lens body 1002. intraocular lens 1000 with a central region cross-sectional thickness 1006. In certain embodiments disclosed herein, a lens body 202 of an intraocular lens 200 has a central region thickness 206 less than the central region thickness 1006 of others. common lens bodies. In the embodiment of Figure 3B, the thickness 306 is further reduced compared to a conventional intraocular lens 1000.

Generally, as discussed above, intraocular lenses are implanted in the eye by rolling an intraocular lens and inserting the rolled intraocular lens into a tube. An advantage of a thinner lens body is that the intraocular lens can be rolled more tightly, resulting in being able to use a small tube and a small incision. Another advantage of a thinner lens body is that the intraocular lens can decrease the risks associated with implanting in different locations within the eye. For example, an intraocular lens 200 may be implanted within the anterior chamber. An intraocular lens 200 may also be positioned within the posterior chamber so that the first portion 216 of the posterior surface 210 floats above the natural lens. The contact potential between the posterior surface 210 of the intraocular lens 200 and the natural lens will be reduced due to the reduced thickness of the intraocular lens 200. For example, the intraocular lens 200 may engage or attach to the ciliary sulcus (sometimes referred to in the present document “fixed in the groove”). An intraocular lens 200 may also be implanted in the capsular bag, as illustrated in Figure 9. Depending on the location of the intraocular lens within the eye, the dimensions of the intraocular lens 200 may be adjusted, including, but not limited to, the opening. of mask 208.

The intraocular lens 200 and/or the lens body 202 may be made of one or more materials. In certain embodiments, the intraocular lens 200 and/or the lens body 202 may comprise polymers (e.g., PMMA, PVDF, polypropylene, polycarbonate, PEEK, polyethylene, acrylic copolymers, polystyrene, PVC, polysulfone), hydrogels, and silicone.

II. Masks that provide depth of focus correction

A variety of mask variations that may be positioned on or within the implant body 2014 are discussed herein and are also described in U.S. Patent No. 7,628,810, U.S. Patent Publication No. 2006/0113054. and US Patent Publication No. 2006/0265058. Figure 11A illustrates one embodiment of a mask 2034a. The mask 2034a may include an annular region 2036a surrounding an aperture or pinhole aperture 2038a located substantially centrally in the mask 2034a. The pinhole aperture 2038a may be generally located about a central axis 2039a, referred to herein as the optical axis of the mask 2034a. The small hole opening 2038a may be in the shape of a circle. Figure 11B illustrates another embodiment of a mask 2034b similar to the mask 2034a illustrated in Figure 11A. The annular region 2036a of the mask 2034a of Figure 11A has a curvature from the outer periphery to the inner periphery of the annular region 2036a; while the annular region 2036b of the mask 2034b of Figure 11B is substantially planar.

The mask may have dimensions configured to function with the implant body to improve a patient's vision. For example, the thickness of the mask may vary depending on the location of the mask with respect to the implant body. For example, if the mask is embedded within the implant body, the mask may have a thickness greater than zero and less than the thickness of the implant body. Alternatively, if the mask is attached to a surface of the implant body, the mask may preferably have a thickness no greater than necessary to have the desired opacity so that the mask does not add additional thickness to the intraocular lens. In certain embodiments, the mask has a thickness greater than zero and less than about 0.5 mm. In one embodiment, the mask has a thickness of about 0.25 mm. If the mask is on or near the surface of the transition zone, the mask may have a shape similar to or the same as the transition zone.

The mask can have a constant thickness, as discussed below. However, in some embodiments, the thickness of the mask may vary between the inner periphery (near the opening 2038) and the outer periphery. Figure 12 shows a mask 2034k having a gradually decreasing thickness from the inner periphery to the outer periphery. Figure 13 shows a mask 2034l having a gradually increasing thickness from the inner periphery to the outer periphery. Other cross section profiles are also possible.

The annular region 2036 may be at least partially opaque or may be completely opaque. The degree of opacity of the annular region 2036 prevents at least some or substantially all of the light from being transmitted through the mask 2032. The opacity of the annular region 2036 can be achieved in any of several different ways.

For example, in one embodiment, the material used to make the mask 2034 may be naturally opaque. Alternatively, the material used to make the mask 2034 may be substantially transparent, but treated with a dye or other pigmenting agent to make the region 2036 substantially or completely opaque. In yet another example, the surface of the mask 2034 can be treated physically or chemically (such as by etching) to alter the refraction and transmission properties of the mask 2034 and make it less transmissive to light.

In yet another alternative, the surface of the mask 2034 may be treated with particles deposited thereon. For example, titanium, gold, or carbon particles may be deposited on the surface of the mask 2034 to provide opacity to the surface of the mask 2034. In another alternative, the particulate may be encapsulated within the interior of the mask 2034, as generally shown. in Figure 14. Finally, the mask 2034 may be patterned to provide areas of variable light transmissivity.

In another embodiment, the mask may be formed from coextruded rods made of material having different light transmission properties. The coextruded rod can then be cut to provide discs for a plurality of masks, such as those described herein.

Other embodiments employ different ways of controlling light transmissivity through a mask. For example, the mask may be a disk filled with gel, as shown in Figure 14. The gel may be a hydrogel or collagen, or other suitable material that is biocompatible with the mating of the mask and can be introduced into the interior of the mask. The gel within the mask may include particulate material 2066 suspended within the gel. Examples of suitable particulate material are gold, titanium and carbon particulate material, which, as discussed above, can alternatively be deposited on the surface of the mask.

The mask material 2034 can be any polymeric material. When the 2034 mask is applied to the intraocular implant, the 2034 mask material must be biocompatible. When a gel is used, the material is suitable to contain a gel. Examples of suitable materials for mask 2034 include the preferred polymethylmethacrylate or other suitable polymers or copolymers, such as hydrogels, and the like. Of course, as noted above, for non-gel-filled materials, a preferred material may be a fibrous material, such as a Dacron mesh.

Figures 15 and 16 illustrate an embodiment in which a mask 2034w comprises a plurality of nanoscopic elements 2068. The "nanoscopic elements" are small particulate structures that have been adapted to selectively transmit or block light entering the patient's eye. The particles can be of a very small size typical of particles used in nanotechnology applications. The nanoscopic elements 2068 are suspended in the gel or otherwise inserted into the interior of the mask 2034w, as generally shown in Figures 15 and 16. The nanoscopic elements 2068 can be preprogrammed to respond to different light environments.

Therefore, as shown in Figure 15, in a high light environment, the nanoscopic elements 2068 rotate and position themselves to substantially and selectively block part of the light from entering the eye. However, in a low light environment where it is desirable for more light to enter the eye, the nanoscopic elements can respond by rotating or otherwise positioning themselves to allow more light to enter the eye, as shown in Figure 16.

Nanodevices or nanoscopic elements are crystalline structures grown in laboratories. Nanoscopic elements can be treated so that they are receptive to different stimuli such as light. According to one aspect of certain embodiments, the nanoscopic elements may be energized where, in response to low light and high light environments, they rotate in the manner described above and generally shown in Figure 16.

Nanoscale devices and systems and their fabrication are described in Smithet al., “Nanofabrication,” Physics Today, February 1990, pp. 24-30 and in Craighead, “Nanoelectromechanical Systems”, Science, November 24, 2000, vol. 290, pp. 1502-1505. Adaptation of the properties of small particle sizes for optical applications is disclosed in Chenet al. “Differactive Phase Elements Based on Two-Dimensional Artificial Dielectrics,” Optical Letters, January 15, 1995, vol. 20, no.2, pp. 121-123.

In additional embodiments, a photochromic material may be used as a mask or in addition to the mask. In bright light conditions, the photochromic material can darken, creating a mask and improving near vision. In dim light conditions, the photochromic lightens, allowing more light to pass through the retina. In certain embodiments, in dim light conditions, the photochromic is lightened to expose an optic of the intraocular implant.

The mask can have different degrees of opacity. For example, the mask may block substantially all visible light or may block a portion of visible light. Mask opacity can also vary in different regions of the mask. In certain embodiments, the opacity of the outer edge and/or inner edge of the mask is less than the central region of the mask. The opacity in different regions can make an abrupt transition or have a gradient transition. Additional examples of opacity transitions can be found in US Patents 5,662,706, 5,905,561 and 5,965,330.

In some embodiments, the mask 2034 is attached or secured to the eye 2010 by support strands 2072 and 2074 shown in Figure 17 and generally described in US Patent No. 4,976,732.

Additional details of the mask are disclosed in U.S. Patent No. 4,976,732, issued December 11, 1990, and U.S. Patent Application No. 10/854,033, filed May 26, 2004.

An advantage of embodiments that include a mask with an aperture (e.g., pinhole aperture) described herein over multifocal IOLs, contact lenses, or corneal treatments is that all of these latter approaches divide the available light entering through the aperture in two or more foci, while a mask focus has a single focus (monofocal). This limitation forces designers of multifocal optics to choose how much light is directed to each focal point, and deal with the effects of out-of-focus light that is always present in any image. To maximize acuity at the important distances of infinity (>6 M) and 40 cm (normal reading distance), it is typical to provide little or no focused light at an intermediate distance, and as a result, visual acuity at these distances is poor. .

With an aperture to increase the depth of focus, however, the presbyopic patient's intermediate vision is significantly improved. In fact, blurring with the pinhole aperture is less at intermediate distances than up close. This can be seen in Figure 59, which is a graph of visual acuity versus defocus comparing one embodiment of an ophthalmic device with one aperture and two commercially available multifocal IOLs. Although greater visual acuity is obtained with multifocal IOLs at very close distances (33 cm, -3D), in the range of 1 M (-1D) to 40 cm (-2.5D), the pinhole aperture may improve the performance of a multifocal optic in an intermediate range.

Visual acuity is measured in logMAR and is the log of the minimum angle of resolution or the smallest angular spacing that can be seen, and is independent of viewing distance. A logMAR value of 0 means 20/20, 6/6, or a decimal acuity of 1 at distance, and equivalent to a Jaeger near acuity 1 (J1). Defocus is measured in diopters, which are the reciprocal of the eye's focal length in meters. Therefore, -1D defocus means the eye focuses at 1/1 = 1 meter. The conventional reading distance (US and Europe) is 40 cm, which is -2.5 D of defocus (1/0.4=2.5).

III. UV resistant polymeric mask materials

Because the mask has a very high surface area to volume ratio and is exposed to a large amount of sunlight after implantation, the mask preferably comprises a material that has good resistance to degradation, including by ultraviolet exposure. (UV) or other wavelengths of light. Polymers that include a UV-absorbing component, including those comprising UV-absorbing additives or made with UV-absorbing monomers (including comonomers), may be used in the formation of masks as disclosed herein that are resistant to degradation by UV radiation. Examples of such polymers include, but are not limited to, those described in US Patent Nos. 4,985,559 and 4,528,311. In a preferred embodiment, the mask comprises a material that itself is resistant to degradation by UV radiation. In one embodiment, the mask comprises a polymeric material that is substantially reflective or transparent to UV radiation. The lens body may include a UV-absorbing component in addition to the mask being resistant to UV radiation degradation or the mask may not be resistant to UV radiation degradation since the UV-absorbing component in the lens body may avoid degradation of the mask due to UV radiation.

Alternatively, the mask may include a component that confers a degradation resistive effect, or may be provided with a coating, preferably at least on the front surface, that confers degradation resistance. Such components may be included, for example, by blending one or more degradation-resistant polymers with one or more other polymers. Such mixtures may also comprise additives that provide desirable properties, such as UV absorbing materials. In one embodiment, the blends preferably comprise a total of about 1-20% by weight, including about 1-10% by weight, 5-15% by weight and 10-20% by weight of one or more polymers. resistant to degradation. In another embodiment, the blends preferably comprise a total of about 80-100% by weight, including about 80-90% by weight, 85-95% by weight and 90-100% by weight of one or more polymers. resistant to degradation. In another embodiment, the mixture has more equivalent proportions of materials, comprising a total of about 40-60% by weight, including about 50-60% by weight and 40-50% by weight of one or more polymers resistant to Degradation. Masks may also include blends of different types of degradation-resistant polymers, including those blends comprising one or more generally transparent or UV-reflective polymers with one or more polymers incorporating UV-absorbing additives or monomers. These blends include those having a total of about 1-20% by weight, including about 1-10% by weight, 5-15% by weight and 10-20% by weight of one or more generally transparent polymers. to UV, a total of about 80-100% by weight, including about 80-90% by weight, 85-95% by weight and 90-100% by weight of one or more generally UV transparent polymers, and a total of about 40-60% by weight, including about 50-60% by weight and 40-50% by weight of one or more generally UV-transparent polymers. The polymer or polymer blend may be blended with other materials as discussed below, including, but not limited to, opacifying agents, polyanionic compounds and/or wound healing modulating compounds. When mixed with these other materials, the amount of polymer or polymer blend in the mask material is preferably about 50%-99% by weight, including about 60%-90% by weight, about 65 -85% by weight, approximately 70-80% by weight and approximately 90-99% by weight.

Preferred degradation resistant polymers include halogenated polymers. Preferred halogenated polymers include fluorinated polymers, that is, polymers having at least one carbon-fluorine bond, including highly fluorinated polymers. The term “highly fluorinated,” as used herein, is a broad term used in its ordinary sense, and includes polymers having at least one carbon-fluorine bond (C-F bond) where the number of C-F bonds is equal to or greater than the number of carbon-hydrogen bonds (C-H bonds). Highly fluorinated materials also include perfluorinated or fully fluorinated materials, materials that include other halogen substituents such as chlorine, and materials that include oxygen- or nitrogen-containing functional groups. For polymeric materials, the number of bonds can be counted by reference to the monomer(s) or repeating units that make up the polymer, and in the case of a copolymer, by the relative amounts of each monomer (on a molar basis). .

Preferred highly fluorinated polymers include, but are not limited to, polytetrafluoroethylene (PFTE or Teflon®), polyvinylidene fluoride (PVDF or Kynar®), poly-1, 1,2-trifluoroethylene and perfluoroalkoxyethylene (PFA). Other highly fluorinated polymers include, but are not limited to, homopolymers and copolymers that include one or more of the following monomer units: tetrafluoroethylene -(CF2-CF2)-; vinylidene fluoride (CF2-CH2)-; 1,1,2-trifluoroethylene -(CF2-CHF)-, hexafluoropropene -(CF(CF3)-CF2); vinyl fluoride -(CH2-CHF)- (the homopolymer is not “highly fluorinated”); oxygen-containing monomers such as -(O-CF2)-, -(O-CF2-CF2)-, -(O-CF(CF3)-CF2)-; chlorine-containing monomers such as -(CF2-CFCl)-. Other fluorinated polymers, such as fluorinated polyimide and fluorinated acrylates, which have sufficient degrees of fluorination are also contemplated as highly fluorinated polymers for use in masks according to preferred embodiments. The homopolymers and copolymers described herein are commercially available and/or the methods for their preparation from commercially available materials are widely published and known to those skilled in the polymer arts.

Although highly fluorinated polymers are preferred, polymers that have one or more carbon-fluorine bonds but do not fall within the definition of “highly fluorinated” polymers as discussed above can also be used. Such polymers include copolymers formed from one or more of the monomers in the preceding paragraph with ethylene, vinyl fluoride or another monomer to form a polymeric material having a greater number of C-H bonds than C-F bonds. Other fluorinated polymers, such as fluorinated polyimide, can also be used. Other materials that could be used in some applications, alone or in combination with a fluorinated or highly fluorinated polymer, are described in US Patent No. 4,985,559 and US Patent No. 4,528,311.

The above definition of highly fluorinated is best illustrated by a few examples. A preferred UV resistant polymeric material is poly(vinylidene fluoride) (PVDf), which has a structure represented by the formula: -(CF2-CH2)n-. Each repeating unit has two C-H bonds, and two C-F bonds. Because the number of C-F bonds is equal to or greater than the number of C-H bonds, PVDF homopolymer is a “highly fluorinated” polymer. Another material is a tetrafluoroethylene/vinyl fluoride copolymer formed from these two monomers in a 2:1 molar ratio. Regardless of whether the copolymer formed is block, random or any other arrangement, from the 2:1 tetrafluoroethylene:vinyl fluoride composition a “repeat unit” can be assumed comprising two tetrafluoroethylene units, each having four C-F bonds, and a vinyl fluoride unit that has three C-H bonds and one C-F bond. The total bonds for two tetrafluoroethylenes and one vinyl fluoride are nine C-F bonds and three C-H bonds. Because the number of C-F bonds is equal to or greater than the number of C-H bonds, this copolymer is considered highly fluorinated.

Certain highly fluorinated polymers, such as PVDF, have one or more desirable characteristics, such as being relatively chemically inert and having a relatively high UV transparency compared to their equivalent non-fluorinated or less highly fluorinated polymers. Although the applicant does not claim to be limited by theory, it is postulated that the electronegativity of fluorine may be responsible for many of the desirable properties of materials having a relatively large number of C-F bonds.

In preferred embodiments, at least a portion of the highly fluorinated polymeric material that forms the mask comprises an opacifying agent that confers a desired degree of opacity. In one embodiment, the opacification agent provides sufficient opacity to produce the depth of field enhancements described herein, for example, in combination with a transmissive aperture. In one embodiment, the opacifying agent renders the material opaque. In another embodiment, the opacifying agent prevents the transmission of approximately 90 percent or more of the incident light. In another embodiment, the opacifying agent renders the material opaque. In another embodiment, the opacifying agent prevents the transmission of approximately 80 percent or more of the incident light. Preferred opacifying agents include, but are not limited to, organic dyes and/or pigments, preferably black, such as azo dyes, hematoxylin black, and Sudan black; inorganic dyes and/or pigments, including metal oxides such as iron oxide black and ilminite, silicon carbide and carbon (e.g., carbon black, submicron powdered carbon). The above materials can be used alone or in combination with one or more other materials. The opacifying agent may be applied to one or more surfaces of the mask on all or part of the surface, or may be mixed or combined with the polymeric material (for example, mixed during the melting phase of the polymer). Although any of the above materials can be used, carbon has been found to be especially useful because it does not fade over time as many organic dyes do, and it also helps the UV stability of the material by absorbing UV radiation. In one embodiment, carbon may be blended with polyvinylidene fluoride (PVDF) or another polymer composition comprising highly fluorinated polymer such that the carbon comprises from about 2% to about 20% by weight of the resulting composition, included from about 10% to about 15% by weight, including about 12%, about 13% and about 14% by weight of the resulting composition.

Some opacifying agents, such as pigments, that are added to blacken, darken, or opacify portions of the mask may cause the mask to absorb incident radiation to a greater degree than mask material that does not include such agents. Because the matrix polymer carrying or including the pigments may be subject to degradation from absorbed radiation, it is preferred that the mask, which is thin and has a high surface area making it vulnerable to environmental degradation, be made of a material that is itself resistant to degradation, such as by UV radiation, or that is generally transparent or non-absorbent of UV radiation. The use of a highly UV-resistant and degradation-resistant material, such as PVDF, which is highly transparent to UV radiation, allows greater flexibility in the choice of opacifying agent because the possible damage to the polymer caused by the selection of a particular opacifying agent is greatly reduced.

Several variations of the above embodiments of degradation-resistant constructions are contemplated. In a variation, a mask is made almost exclusively of a material that is not subject to UV degradation. For example, the mask may be made of a metal, a highly fluorinated polymer, carbon (e.g., graphene, pure carbon), or the like. The construction of the mask with metal is discussed in more detail in US application 11/000,562 filed on December 1, 2004 and entitled “Method of Making an Ocular Implant” and also in US application 11/107,359 filed on April 14 of 2005 with the title “Method of Making an Ocular Implant”. As used in this context, “exclusively” is a broad term that allows for the presence of some non-functional materials (e.g., impurities) and an opacifying agent, as discussed above. In other embodiments, the mask may include a combination of materials. For example, in one variation, the mask is primarily formed of any implantable material and is coated with a UV resistant material. In another variation, the mask includes one or more UV degradation inhibitors and/or one or more UV degradation resistant polymers in sufficient concentration so that the mask, under normal conditions of use, maintains sufficient functionality in terms of the degradation to remain medically effective for at least about 5 years, preferably at least about 10 years, and, in certain implementations, at least about 20 years.

Figure 23 is a flow chart illustrating methods for manufacturing a masked intraocular implant from a mask comprising a highly fluorinated polymer and an opacifying agent. The method of Figure 23 includes a first method 3014 of manufacturing a mask of highly fluorinated polymer and opacification agent and a second method 3026 of manufacturing an intraocular implant with the mask manufactured from the first method 3014.

In step 3000, a liquid form of a polymer is created by dissolving poly(vinylidene fluoride) (PVDF) granules in a solvent such as dimethylacetamide (DMAC or DMA) using heat until the PVDF has completely dissolved. In one embodiment, the solution can be mixed for a minimum of 12 hours to ensure that the PVDF has completely dissolved. In step 3200, the PVDF/DMAC solution is mixed with an opacifying agent, such as a dye or carbon black, using a high speed shear mixer. In one embodiment, the carbon black comprises 13% by weight of the resulting composition while the PVDF comprises 87% by weight of the resulting composition. In step 3300, the PVDF/carbon black solution is optionally milled in a high speed mill, for example, a high speed Eiger mill, to break up any large carbon agglomerates in the solution. The PVDF/carbon black solution can be passed through the mill a second time to further break up any carbon agglomerate. In step 3400, the resulting solution is applied to a silicon wafer to create a polymer film on the silicon wafer.

In this case, approximately 55 g of the PVDF/carbon black solution is poured into a dispensing cylinder for application to a silicon wafer. The silicon wafer is placed in the centrifuge of a spin casting machine and the dispensing cylinder is used to apply a PVDF/carbon black solution bead to the silicon wafer in a circular pattern, leaving the diameter 1' ' center of the empty disk. The centrifuge cycle is actuated to disperse the PVDF/carbon black solution over the disc, forming a uniform film 10 micrometers thick. Polymer film can also be deposited, spray coated, etc. to a silicon wafer. The coated silicon wafer is then placed on a hot plate to evaporate the DMAC. In step 3500, the coated silicon wafer is placed under an excimer laser. A laser cutting mask is mounted on the laser and the laser is actuated. Using laser cutting mask, about 150 mask patterns are laser machined on the PVDF/carbon black film. Mask patterns can also be formed using a punching technique, electron beam, etching, etc. The mask patterns are arranged so that no material is used that extends approximately 5 mm from the edge of the silicon wafer. During laser machining, the silicon wafer can be bathed in nitrogen gas to cool the surface. In step 3600, the laser machined masks are removed from the silicon wafer using a razor blade. An optional step may include placing the laser machined mask into a forming mold. The mold may have any desired shape, such as a flat mold, a convex mold, a concave mold, or a mold with a more complex shape. The mask can be placed on the lower half of the forming mold in one technique. The top half of the forming mold can be placed on top of the mask and the molds can be placed in an oven at approximately 160°C. The molds are then heated and baked to form the masks. The molds are left to bake for approximately two hours at approximately 160 °C. After two hours, the oven temperature is reduced to approximately 30°C and the masks are baked for approximately two hours or until the oven temperature has dropped to below approximately 40°C.

In step 3016, the inlay (e.g., mask) manufactured in the first method 3014 is placed in a mold form. In one embodiment, silicone or other lens material is injected into the mold form and around the inlay. In step 3018, the silicone is cured to form an implant body. In step 3020, the intraocular implant is polished, and in step 3022, the implant body is removed from the mold form. At step 3024, one or more haptics may be attached (e.g., linked) to the implant body to form an intraocular implant. Step 3024 may be included for a three-piece IOL design, but may not be necessary for other designs. In certain embodiments, the one or more haptics are formed with the implant body during the injection process. For example, the implant body can be turned and the haptics milled from a single piece. The intraocular implant can be inspected afterwards (e.g. cosmetic, diopter, resolution).

IV. Masks configured to reduce visible diffraction patterns

Many of the masks above can be used to improve a patient's depth of focus. Various additional mask embodiments are discussed below. Some of the embodiments described below include light transmission holes through the annular region of the mask to change the amount of light blocked by the annular region. Light transmission holes through the mask can improve a patient's dim or low-light vision. In certain light transmission hole arrangements, the light transmission holes can generate diffraction patterns that interfere with the vision-enhancing effect of the masks described herein. Accordingly, certain masks are described herein that include light transmission holes that do not generate diffraction patterns or otherwise interfere with the vision-enhancing effects of the mask embodiments.

Figures 18-19 show one embodiment of a mask 2100 configured to increase the depth of focus of an eye of a patient with presbyopia. The mask 2100 is similar to the masks described previously herein, except as described differently below. The mask 2100 may be made of the materials discussed herein, including those discussed above. Furthermore, the mask 2100 may be formed by any suitable process. Mask 2100 is configured to be applied to an IOL.

In one embodiment, the mask 2100 includes a body 2104 having a front surface 2108 and a back surface 2112. The body 2104 may be formed of any suitable material, including at least one of an open cell foam material, a solid material expanded and a substantially opaque material. In one embodiment, the material used to form the body 2104 has a relatively high water content. In other embodiments, materials that may be used to form the body 2104 include polymers (e.g., PMMA. PVDF, polypropylene, polycarbonate, PEEK, polyethylene, acrylic copolymers (e.g., hydrophobic or hydrophilic), polystyrene, PVC, polysulfone), hydrogels, silicone, metals, metal alloys or carbon (e.g. graphene, pure carbon).

In one embodiment, the mask 2100 includes a light transmission hole arrangement 2116. The light transmission hole arrangement 2116 may comprise a plurality of holes 2120. The holes 2120 are shown in only a portion of the mask 2100, but The holes 2120 are preferably located throughout the body 2104 in one embodiment. In one embodiment, the holes 2120 are arranged in a hexagonal pattern, which is illustrated by a plurality of locations 2120' in Figure 20A. As discussed below, a plurality of locations may be defined and used in the subsequent formation of a plurality of holes 2120 in the mask 2100. The mask 2100 has an outer periphery 2124 that defines an outer edge of the body 2104. In some embodiments, The mask 2100 includes an opening 2128 surrounded at least partially by the outer periphery 2124 and a non-transmissive portion 2132 located between the outer periphery 2124 and the opening 2128.

Preferably, the mask 2100 is symmetrical, e.g., symmetrical about a mask axis 2136. In accordance with the invention, the outer periphery 2124 of the mask 2100 is circular. The mask generally has a diameter within the range of about 3 mm to about 8 mm, often within the range of from 3.5 mm to about 6 mm, and less than about 6 mm in one embodiment. In another embodiment, the mask is circular and has a diameter in the range of 4 to 6 mm. In another embodiment, the mask 2100 is circular and has a diameter of less than 4 mm. The outer periphery 2124 has a diameter of approximately 3.8 mm in another embodiment. In some embodiments, masks that are asymmetrical or that are not symmetrical about a mask axis provide benefits, such as allowing a mask to be located or maintained in a selected position with respect to the anatomy of the eye.

The body 2104 of the mask 2100 may be configured to mate with a particular intraocular lens design, either of a reduced thickness design or of a conventional design. For example, when the mask 2100 is to be coupled with a particular IOL that has curvature, the body 2104 may be provided with a corresponding amount of curvature along the mask axis 2136 that corresponds to the curvature. Likewise, the body 2104 may be shaped accordingly to accommodate the transition zones of the IOL.

In some embodiments, the mask 2100 has a desired amount of optical power. Optical power may be provided by configuring the at least one of the front and rear surfaces 2108, 2112 with curvature. In one embodiment, the front and rear surfaces 2108, 2112 are provided with different amounts of curvature. In this embodiment, the mask 2100 has a variable thickness from the outer periphery 2124 to the opening 2128.

In one embodiment, one of the front surface 2108 and the rear surface 2112 of the body 2104 is substantially planar. In a planar embodiment, very little or no uniform curvature can be measured across the planar surface. In another embodiment, both front and rear surfaces 2108, 2112 are substantially planar. In general, the thickness of the body 2104 of the mask 2100 may be within the range of greater than zero to about 0.5 mm. In another embodiment, the thickness 2138 of the mask 2100 is approximately 0.25 mm.

A substantially flat mask has several advantages over a non-planar mask. For example, a substantially flat mask can be made more easily than one that has to be formed to a particular curvature. In particular, the process steps involved in inducing curvature in the mask 2100 can be eliminated.

Aperture 2128 is configured to transmit substantially all incident light along mask axis 2136. Non-transmissive portion 2132 surrounds at least a portion of aperture 2128 and substantially prevents transmission of incident light thereon. As discussed in connection with the previous masks, the opening 2128 may be a through hole in the body 2104 or a substantially light transmissive (e.g., transparent) portion thereof. The opening 2128 of the mask 2100 is generally defined within the outer periphery 2124 of the mask 2100. The opening 2128 may take on any of suitable configurations, such as those described above.

In one embodiment, the aperture 2128 is substantially circular and is substantially centered in the mask 2100. The size of the aperture 2128 may be any size that is effective to increase the depth of focus of an eye of a patient suffering from presbyopia. In particular, the size of the aperture 2128 depends on the location of the mask within the eye (e.g., distance from the retina). In accordance with the invention, in the intraocular space of the eye, the opening 2128 may be circular, and has a diameter of less than about 2 mm. In another embodiment, the diameter of the opening is between about 1.1 mm and about 1.6 mm. In another embodiment, the opening 2128 is circular and has a diameter of approximately 1.6 mm or less. Most apertures will have a diameter within the range of about 0.85 mm, and often within the range of from about 1.1 mm to about 1.7 mm.

In certain embodiments, aperture 2128 includes optical power and/or refraction properties. For example, aperture 2128 may include an optic and may have an optical power (e.g., positive or negative optical power). In certain embodiments, aperture 2128 may correct refractive errors of an eye.

The non-transmissive portion 2132 is configured to prevent the transmission of radiant energy through the mask 2100. For example, in one embodiment, the non-transmissive portion 2132 prevents the transmission of substantially all of at least a portion of the spectrum of the radiant energy. incident. In one embodiment, the non-transmissive portion 2132 is configured to prevent the transmission of substantially all visible light, e.g., radiant energy in the electromagnetic spectrum that is visible to the human eye. The non-transmissive portion 2132 can substantially prevent the transmission of radiant energy outside the range visible to humans in some embodiments.

As discussed above, avoiding light transmission through the non-transmissive portion 2132 decreases the amount of light reaching the retina and fovea that would not converge on the retina and fovea to form a sharp image. As discussed above, the size of the aperture 2128 is such that light transmitted through it generally converges on the retina or fovea. Consequently, a much sharper image is presented to the eye than would be the case without the 2100 mask.

In one embodiment, the non-transmissive portion 2132 prevents the transmission of at least about 90 percent of the incident light. In another embodiment, the non-transmissive portion 2132 prevents the transmission of at least about 95 percent of all incident light. The non-transmissive portion 2132 of the mask 2100 may be configured to be substantially opaque to prevent light transmission. As used herein, the term "opaque" is intended to indicate a transmission of no more than about 2% of the incident visible light. In one embodiment, at least a portion of the body 2104 is configured to be opaque to greater than 99 percent of the light incident thereon.

As discussed above, non-transmissive portion 2132 may be configured to prevent light transmission without absorbing incident light. For example, mask 2100 could be made reflective or could be made to interact with light in a more complex manner, as discussed in U.S. Patent No. 6,554,424, issued April 29, 2003.

As discussed above, the mask 2100 also has light transmission holes which, in some embodiments, comprises the plurality of holes 2120. The presence of the plurality of holes 2120 (or other light transmission structures) may affect the transmission of light through the non-transmissive portion 2132 potentially allowing more light to pass through the mask 2100. In one embodiment, the non-transmissive portion 2132 is configured to absorb approximately 98 percent or more of the incident light that passes through. through the mask 2100 without holes 2120 being present. The presence of the plurality of holes 2120 allows more light to pass through the non-transmissive portion 2132 so that only approximately 95 percent of the incident light is prevented from passing through. in the non-transmissive portion 2132 through the non-transmissive portion 2132. The holes 2120 may reduce the benefit of the aperture 2128 on the depth of focus of the eye by allowing more light to pass through the non-transmissive portion to the retina.

As discussed above, the holes 2120 of the mask 2100 shown in Figure 18A can be located anywhere on the mask 2100. Other mask embodiments described hereinbelow locate substantially all of the light transmission holes in one or more regions of a mask.

The holes 2120 of Figure 18A extend at least partially between the front surface 2108 and the rear surface 2112 of the mask 2100. In one embodiment, each of the holes 2120 includes an orifice inlet 2160 and an orifice exit 2164. The orifice inlet 2160 is located adjacent to the front surface 2108 of the mask 2100. The orifice exit 2164 is located adjacent to the rear surface 2112 of the mask 2100. In one embodiment, each of the orifices 2120 extends the entire length of the mask 2100. distance between the front surface 2108 and the back surface 2112 of the mask 2100.

In one embodiment, the holes 2120 have a diameter in the range of about 0.002 mm to about 0.050 mm. In certain embodiments, the holes 2120 have a diameter of about 0.005 mm or more. In another embodiment, the holes have a diameter of approximately 0.020 mm. In another embodiment, the holes have a diameter of approximately 0.025 mm. In another embodiment, the holes have a diameter of approximately 0.027 mm. In another embodiment, the holes 2120 have a diameter in the range of about 0.020 mm to about 0.029 mm. In one embodiment, the number of holes in the plurality of holes 2120 is selected so that the sum of the surface areas of the hole inlets 2140 of all the holes 2100 comprises approximately 5 percent or more of the surface area of the front surface 2108 of the mask 2100. In another embodiment, the number of holes 2120 is selected so that the sum of the surface areas of the hole exits 2164 of all the holes 2120 comprises approximately 5 percent or more of the surface area of the back surface 2112 of the mask 2100. In another embodiment, the number of holes 2120 is selected so that the sum of the surface areas of the hole exits 2164 of all the holes 2120 comprises approximately 5 percent percent or more of the surface area of the back surface 2112 of the mask 2112 and the sum of the surface areas of the orifice inlets 2140 of all orifices 2120 comprises approximately 5 percent or more of the surface area of the surface anterior 2108 of the mask 2100. In another embodiment, the plurality of holes 2120 may comprise approximately 1600 microperforations. In another embodiment, the plurality of holes 2120 comprises approximately 8400 microperforations.

Each of the holes 2120 may have a relatively constant cross-sectional area. In one embodiment. the cross-sectional shape of each of the holes 2120 is substantially circular. Each of the holes 2120 may comprise a cylinder extending between the front surface 2108 and the rear surface 2112.

The relative position of the holes 2120 is of interest in some embodiments. As discussed above, the holes 2120 of the mask 2100 are hexagonally packed, e.g., arranged in a hexagonal pattern. In particular, in this embodiment, each of the holes 2120 is separated from adjacent holes 2120 by a substantially constant distance, sometimes referred to herein as a hole pitch. In one embodiment, the hole pitch is approximately 0.045 mm.

In a hexagonal pattern, the angles between the lines of symmetry are approximately 43 degrees. The separation between any two neighboring holes is generally in the range of about 30 micrometers to about 100 micrometers, and, in one embodiment, is about 43 micrometers. The hole diameter is generally within the range of about 2 micrometers to about 100 micrometers, and in one embodiment, it is about 20 micrometers. Light transmission is a function of the sum of hole areas as those skilled in the art will understand in view of the disclosure herein.

Negative visual effects may arise due to the presence of the light transmission hole arrangement 2116. For example, in some cases, a hexagonally packed arrangement of the holes 2120 may generate diffraction patterns visible to the patient. For example, patients could observe a plurality of spots, for example, six spots, surrounding a central lumen with holes 2120 having a hexagonal pattern.

A variety of techniques are possible that produce advantageous arrangements of light transmission holes so that diffraction patterns and other detrimental visual effects do not substantially inhibit other visual benefits of a mask. In one embodiment, where diffraction effects were observable, the light transmission holes are arranged to propagate the diffracted light outward uniformly across the image to eliminate observable specks. In another embodiment, the light transmission holes employ a pattern that substantially eliminates diffraction patterns or pushes the patterns to the periphery of the image.

Figures 20B-20C show two embodiments of hole patterns 2220' that can be applied to a mask that is otherwise substantially similar to the mask 2100. The holes 2220' of the hole patterns of Figures 20B-20C are spaced apart. yes by a random hole spacing or hole pitch. In other embodiments discussed below, the holes are spaced apart from each other by a non-uniform amount, not a random amount. In one embodiment, the holes 2220' have a substantially uniform shape (cylindrical shafts having a substantially constant cross-sectional area). Figure 20C illustrates a plurality of holes 2220' separated by a random spacing, where the density of the holes is greater than that of Figure 20B. Generally, the greater the percentage of the mask body that has holes, the more the mask will allow light to transmit through the mask. One way to provide a higher percentage of hole area is to increase the hole density. Increasing hole density may also allow smaller holes to achieve the same light transmission as achieved with larger, less dense holes.

Figure 21A shows a portion of another mask 2200a that is substantially similar to mask 2100, except described differently below. The mask 2200a may be made of the materials discussed herein, including those discussed above. The mask 2200a may be formed by any suitable process, such as those discussed herein and with variations of such processes. The mask 2200a has an arrangement of light transmission holes 2216a that includes a plurality of holes 2220a. A substantial number of the holes 2220a have a non-uniform size. The holes 2220a may have a uniform cross-sectional shape. The cross-sectional shape of the holes 2220a is substantially circular in one embodiment. The orifices 2220a may be circular in shape and have the same diameter from an orifice inlet to an orifice exit, but are otherwise not uniform in at least one aspect, for example, in size. It may be preferable to vary the size of a substantial number of holes by a random amount. In another embodiment, the holes 2220a are non-uniform (e.g., random) in size and are separated by a non-uniform (e.g., random) spacing.

Figure 21B illustrates another embodiment of a mask 2200b that is substantially similar to mask 2100, except described differently below. The mask 2200b may be made of the materials discussed herein. Furthermore, mask 2200b may be formed by any suitable process, such as those discussed herein and with variations of such processes. The mask 2200b includes a body 2204b. The mask 2200b has an arrangement of light transmission holes 2216b that includes a plurality of holes 2220b with a non-uniform facet orientation. In particular, each of the orifices 2220b has an orifice inlet that may be located on a front surface of the mask 2200b. A facet of the orifice inlet is defined by a portion of the body 2204b of the mask 2200b that surrounds the orifice inlet. The facet is the shape of the hole entrance on the anterior surface. In one embodiment, most or all of the facets have an elongated shape, for example, an oblong shape, with a long axis and a short axis that is perpendicular to the long axis. The facets may have a substantially uniform shape. In one embodiment, the orientation of the facets is not uniform. For example, a substantial number of the facets may have a non-uniform orientation. In an arrangement, a substantial number of the facets have a random orientation. In some embodiments, the facets are not uniform (e.g., random) in shape and are not uniform (e.g., random) in orientation.

Other embodiments varying in at least one aspect, including one or more of the above aspects, of a plurality of holes may be provided to reduce the tendency of the holes to produce visible diffraction patterns or patterns that otherwise reduce the enhancement of the vision that a mask with an opening, such as any of those described above, can provide. For example, in one embodiment, the hole size, shape and orientation of at least a substantial number of the holes may vary randomly or may otherwise be non-uniform. The mask may also be characterized in that at least one of the hole size, shape, orientation and spacing of a plurality of holes varies to reduce the tendency of the holes to produce visible diffraction patterns. In certain embodiments, the tendency of the holes to produce visible diffraction patterns is reduced by having a plurality of holes having a first hole size, shape or spacing and at least another plurality of holes having a second hole size, shape or spacing. spacing different from the first hole size, shape or spacing. In other embodiments, the mask is characterized in that at least one of the orifice size, shape, orientation and spacing of a substantial number of the plurality of orifices is different from at least one of the orifice size, shape, orientation and spacing of at least another substantial number of the plurality of holes to reduce the tendency of the holes to produce visible diffraction patterns. In further embodiments, the holes are located at irregular locations. For example, the holes are located at irregular locations to minimize the generation of visible artifacts due to light transmission through the holes.

Figure 22 shows another embodiment of a mask 2300 that is substantially similar to any of the masks previously described herein, except described differently below. The mask 2300 may be made of the materials discussed herein. Furthermore, mask 2300 may be formed by any suitable process, such as those discussed herein and with variations of such processes. The mask 2300 includes a body 2304. The body 2304 has an outer peripheral region 2305, an inner peripheral region 2306, and an orifice region 2307. The orifice region 2307 is located between the outer peripheral region 2305 and the inner peripheral region 2306. The body 2304 may also include an opening region 2328, where the opening (discussed below) is not a through hole. The mask 2300 also includes a light transmission hole arrangement 2316. In one embodiment, the light transmission hole arrangement includes a plurality of holes. At least a substantial portion of the holes (e.g., all of the holes) are located in the hole region 2307. As above, only a portion of the light transmission hole arrangement 2316 is shown for simplicity. But it should be understood that the hole arrangement may be located throughout the hole region 2307.

The outer peripheral region 2305 may extend from an outer periphery 2324 of the mask 2300 to a selected outer circumference 2325 of the mask 2300. The selected outer circumference 2325 of the mask 2300 is located a selected radial distance from the outer periphery 2324 of the mask 2300. In one embodiment, the selected outer circumference 2325 of the mask 2300 is located approximately 0.05 mm from the outer periphery 2324 of the mask 2300.

The inner peripheral region 2306 may extend from an inner location, for example, an inner periphery 2326 adjacent to an opening 2328 of the mask 2300 to a selected inner circumference 2327 of the mask 2300. The selected inner circumference 2327 of the mask 2300 is located at a selected radial distance from the inner periphery 2326 of the mask 2300. In one embodiment, the selected inner circumference 2327 of the mask 2300 is located approximately 0.05 mm from the inner periphery 2326.

The mask 2300 may be the product of a process that involves randomly selecting a plurality of locations and forming holes in the mask 2300 corresponding to the locations. As further discussed below, the method may also involve determining whether the selected locations satisfy one or more criteria. For example, one criterion prohibits all, at least a majority, or at least a substantial portion of the holes from forming in locations that correspond to the inner or outer peripheral regions 2305, 2306. Another criterion prohibits all, at least a majority or at least a substantial portion of the holes are formed too close together. For example, such a criterion could be used to ensure that a wall thickness, e.g., the shortest distance between adjacent holes, is not less than a predetermined amount. In one embodiment, the wall thickness is prevented from being less than about 20 micrometers.

In a variation of the embodiment of Figure 22, the outer peripheral region 2305 is eliminated and the hole region 2307 extends from the inner peripheral region 2306 to an outer periphery 2324. In another variation of the embodiment of Figure 50, the inner peripheral region 2306 is eliminated and the hole region 2307 extends from the outer peripheral region 2305 to an inner periphery 2326.

In any of the above mask embodiments, the mask body may be formed of a material selected to substantially avoid negative optical effects, such as diffraction, as discussed above. In various embodiments, the masks are formed from an open cell foam material, silicone, thermoset and thermoelastic polymers such as PVDF, PMMA, metal, Teflon or carbon. In another embodiment, the masks are formed from an expanded solid material.

As discussed above in relation to Figures 20B and 20C, various random hole patterns may advantageously be provided. In some embodiments, it may be sufficient to provide regular patterns that are not uniform in some respect. Non-uniform appearances of the holes can be provided by any suitable technique.

In a first step of a technique, a plurality of locations 2220' are generated. Locations 2220' are a series of coordinates that may comprise a non-uniform pattern or a regular pattern. Locations 2220' may be randomly generated or may be related by a mathematical relationship (e.g., separated by a fixed separation or by a quantity that may be mathematically defined). In one embodiment, the locations are selected to be separated by a constant pitch or spacing and may be hexagonally packed.

In a second step, a subset of the locations among the plurality of locations 2220' is modified to maintain a performance characteristic of the mask. The performance characteristic can be any performance characteristic of the mask. For example, the performance characteristic may be related to the structural integrity of the mask. When the plurality of locations 2220' are selected at random, the process of modifying the subset of locations may cause the resulting pattern of holes in the mask to be a “pseudo-random” pattern.

When a pattern of hexagonally packed locations (such as locations 2120' of Figure 20A) is selected in the first step, the subset of locations can be moved with respect to their initial positions as selected in the first step. In one embodiment, each of the locations in the subset of locations is moved by an amount equal to a fraction of the hole spacing. For example, each of the locations in the subset of locations can be moved by an amount equal to one-quarter of the hole spacing. When the subset of locations is moved by a constant amount, the locations that are moved are preferably selected randomly or pseudo-randomly. In another embodiment, the location subset is moved by a random or pseudo-random amount.

In certain embodiments, an outer peripheral region is defined that extends between the outer periphery of the mask and a selected radial distance of approximately 0.05 mm from the outer periphery. In another embodiment, an inner peripheral region is defined that extends between an opening of the mask and a selected radial distance of approximately 0.05 mm from the opening. In another embodiment, an outer peripheral region is defined that extends between the outer periphery of the mask and a selected radial distance and an inner peripheral region is defined that extends between the opening of the mask and a selected radial distance from the opening. In one technique, the location subset is modified by excluding those locations that would correspond to holes formed in the inner peripheral region or the outer peripheral region. By excluding locations in at least one of the outer peripheral region and the inner peripheral region, the strength of the mask in these regions is increased. Various benefits are provided by stronger inner and outer peripheral regions. For example, the mask may be easier to handle during manufacturing or when rolled without causing damage to the mask. In other embodiments, the mask does not include an outer peripheral region and/or inner peripheral region that do not have holes (for example, the holes may extend to the inner periphery and/or the outer periphery).

In another embodiment, the subset of locations is modified by comparing the hole spacing with minimum and/or maximum limits. For example, it may be desirable to ensure that no two locations are closer than a minimum value. In some embodiments, this is important to ensure that the wall thickness, which corresponds to the spacing between adjacent holes, is not less than a minimum amount. As discussed above, the minimum gap value is about 20 micrometers in one embodiment, thereby providing a wall thickness of no less than about 20 micrometers.

In another embodiment, the subset of locations is modified and/or the location pattern is increased to maintain an optical characteristic of the mask. For example, the optical characteristic may be opacity and the subset of locations may be modified to maintain the opacity of a non-transmissive portion of a mask. In another embodiment, the subset of locations may be modified by equating the density of holes in a first body region compared to the density of holes in a second body region. For example, locations corresponding to the first and second regions of the non-transmissive portion of the mask may be identified. In one embodiment, the first region and the second region are arcuate regions (e.g., wedges) of substantially equal area. A first areal density of locations (e.g., locations per square inch) is calculated for the locations corresponding to the first region and a second areal density of locations is calculated for the locations corresponding to the second region. In one embodiment, at least one location is added to the first or second region based on comparison of the first and second areal densities. In another embodiment, at least one location is eliminated based on comparison of the first and second areal densities.

In a third step, a hole is formed in the body of a mask at locations corresponding to the modified, augmented, or modified and augmented pattern of locations. The holes are configured to allow at least some light transmission through the mask without producing visible diffraction patterns.

V. Additional skin settings

A skin can have a variety of other configurations including configurations that include features described above. For example, the density of light transmission holes (e.g., hole area per mask area) may be different in different areas of the mask. In certain embodiments, the hole density increases radially from the inner periphery to the outer periphery of the mask. In certain other embodiments, the hole density decreases radially from the inner periphery to the outer periphery of the mask. Other variations are also possible. For example, a central annular region of the mask 4000 may have a higher hole density than an inner annular region and an outer annular region, as illustrated in Figure 24A. In another example, the central annular region of a mask has a lower hole density than an inner annular region and an outer annular region. Hole density is the percentage of the surface area of the mask that has holes. A density of holes can be created by, for example, relatively few holes with relatively large area or relatively many holes with relatively small area. As described above, the holes may be arranged to reduce visible diffraction patterns.

The mask embodiment 4000 illustrated in Figure 24A has an irregular hole pattern as described in section IV. The mask 4000 includes an inner peripheral region adjacent to the inner periphery of the mask 4000, an outer peripheral region adjacent to the outer periphery of the mask 4000, and ten annular bands between the inner peripheral region and the outer peripheral region. The first band of the ten annular bands is adjacent to the inner peripheral region, the second band is adjacent to the first band, and so on. The tenth band is adjacent to the outer peripheral region. Each band includes 840 holes, and the inner peripheral region and the outer peripheral region do not include holes and are 50 micrometers wide. Each of the bands has a bandwidth, a percentage of light transmission through the band, and a hole diameter for the holes in the band, as illustrated in Table III. The holes in the ten bands provide an average light transmission of 5%. The number and properties of the bands and the number and properties of the holes in each band may vary. For example, the bands can be configured to create a light transmission profile as described above. In certain embodiments, the mask 4000 does not have any inner peripheral region and/or outer peripheral region.

Table III. Properties of the example mask illustrated in Figure 24A.

The hole density transition between the central annular region and the inner and/or outer annular regions may be a gradual radial transition or may be a transition with one or more steps. The change in hole density from one region to another can be done by having the number of holes remain constant while varying the hole size, having the hole size remain constant while varying the number of holes, or a combination of vary the number of holes and hole size. Additional details regarding the hole density transition between the central annular region and the inner and/or outer annular regions are described in the simultaneously filed international patent application entitled “CORNEAL INLAY WITH NUTRIENT TRANSPORT St RUCTURES,” the application International Patent No. TBD (Proxy File No. ACUFO.123VPC) filed on the same day as the present application, claiming the benefit of US Provisional Application No. 61/233,802, by Bruce Christie, Edward W Peterson and Corina van de Pol.

Advantageously, by having at least some light transmission through the mask, the patient's dim light vision can be improved over having substantially no light transmission through the mask. Embodiments include a total area density of mask holes of more than 1%, less than 10%, between 1% and 10%, between 2% and 5%. Embodiments include a light transmittance through the mask of more than 1%, less than 10%, between 1% and 10%, between 2% and 5%. In certain embodiments, the central annular region of the mask has an average light transmittance of between 2% and 5% and the inner annular region and the outer annular region have an average light transmittance of between 1% and 2%. %. In certain embodiments, the inner annular region is the annular region between the inner periphery of the mask and approximately one-third of the radial distance from the inner periphery to the outer periphery of the mask. In certain embodiments, the outer annular region is the annular region between the outer periphery of the mask and approximately one-third of the radial distance from the outer periphery to the inner periphery of the mask. In certain embodiments, the central annular region is the annular region between the inner annular region and the outer annular region.

Advantageously, if the mask is in a position between the posterior and anterior surfaces of a lens body, the holes through the mask can help prevent delamination of the interface between the mask and the lens body. Delamination may occur during handling of the intraocular implant, such as when the intraocular implant is folded or rolled and placed in a tube for implantation in the patient. The lens body may extend through the holes, thus creating a link (e.g., “bridge” of material) between the lens body on either side of the mask. Delamination can also be reduced by matching the mechanical properties (e.g., elastic modulus) of the mask to the lens body. Another method to reduce delamination is to create a bond between the lens body and the mask. For example, the lens body and mask may have cross-linking bonds or van der Waals forces between them.

The holes in the mask serve at least two purposes: the holes provide some light transmission, and the holes create areas where the implant body material can extend to create a “bridge” of material that holds the mask in place. In certain embodiments, the mask includes orifices greater than about 7 micrometers in diameter (e.g., greater than a cross-sectional area of about 35 |im2), and preferably greater than about 10 micrometers in diameter (e.g., greater than an area cross section of approximately 75 |im2). In certain embodiments, the mask includes orifices larger than about 7 micrometers in diameter (e.g., larger than a cross-sectional area of about 35 |im2) and smaller than about 20 micrometers in diameter (e.g., smaller than a cross-sectional area transversal of approximately 320 |im2). In further embodiments, the mask includes holes smaller than about 50 micrometers in diameter (e.g., smaller than a cross-sectional area of about 2000 |im2). Holes with diameters smaller than 7 micrometers may not be large enough for lens material, such as silicone or acrylic, to enter and migrate to form a bridge. However, the viscosity of the lens material will affect whether the material will be able to migrate into the hole to form the bridge and a minimum cross-sectional area of the hole may depend on the material of the implant body. If the implant body material does not migrate into a hole, that hole can create a bubble that could interfere with the visual performance of the implant.

It may be desirable to minimize the total amount of light passing through the mask to maximize the contrast of close-up images. Delamination can be avoided with a relatively small total area of the mask having “bridge” holes. For example, an area of approximately 3% of the mask may include holes that can balance maximizing mechanical strength and minimizing the optical effects of the holes. In certain embodiments, the front surface of the mask has a surface area of the mask, and the light transmission structures (e.g., holes) in the mask have a total area on the front surface of the mask of about 1%. to approximately 5% of the surface area of the mask. To limit the impact of diffraction of light passing through the holes in the mask, the holes can be made as small as possible. The Airy disk of each hole is larger the smaller the hole size, so the composite diffraction pattern produced by the hole pattern also becomes larger. The composite diffraction pattern spreads light over a larger portion of the retina, decreasing the local brightness of the diffracted light and making diffraction artifacts less visible. The diffraction patterns produced by a hole pattern also tend to have a chromatic component so that the diffraction halo tends to grade in color radially. Varying the size of the holes produces this effect at multiple scales, which randomizes the color of the halo. This reduces the color contrast in the halo, making it less noticeable.

In a certain embodiment, the mask includes holes randomly or pseudo-randomly placed throughout the mask. The mask 4100 illustrated in Figure 24B has a light transmission of approximately 3.02%. The mask of Figure 24B has orifices with one of four orifice diameters including 10 micrometers, 13 micrometers, 16 micrometers, and 19 micrometers. There are an equal number of holes with each hole diameter. An algorithm can be used to randomly or pseudo-randomly assign holes of varying sizes to locations across the mask ring. Rules for the randomization program may include (1) that there be no “collisions” of the holes (for example, the holes do not contact each other), (2) that no holes interfere with the inner and outer peripheral edges of the mask, and (3) that the holes are positioned in such a way as to create a substantial uniform density across the mask ring. For example, the rules for the randomization program include one or more of these rules. Figures 24C and 24D illustrate additional hole positioning examples for masks 4200, 4300 using similar parameters as those used for the mask of Figure 24B.

The outer diameter of the outer periphery of the mask may vary. In certain embodiments, the outer diameter is selected to selectively allow an amount of light to pass to the retina of the eye. The pupil of the eye changes size under different lighting conditions. In low light situations, the pupil of the eye enlarges to let more light into the eye. The outer diameter can be selected so that light does not pass outside the outer periphery of the mask under relatively high light conditions, and so that at least some light can pass outside the outer periphery of the mask under relatively high light conditions. relatively low light. Patients' pupil size can often vary; therefore, the outer diameter of the mask can be selected for a patient-specific pupil size. For example, for patients with relatively small pupils, dim light may present more vision problems than for patients with larger pupils. For patients with smaller pupils, a mask with more light transmission and/or a smaller outer diameter will increase the light reaching the retina and improve vision in dim light situations. In contrast, for patients with larger pupils, less light transmission and/or a larger outer diameter mask improve low-contrast near vision and block more out-of-focus light. The masked IOLs of the present application provide the surgeon with flexibility to prescribe the appropriate combination of masked IOL features for particular patients.

In certain embodiments, the center of the mask aperture is offset from the center of the lens body. By having an aperture offset from the optical center of the lens body, the intraocular lens can be rotated during the implantation procedure so that the optical center of the patient's eye can be aligned with the center of the aperture. The patient's vision can be improved by aligning the optical center of the patient's eye with the center of the aperture.

SAW. Ocular implant manufacturing methods

Intraocular implants (for example, intraocular lenses) can be manufactured or produced in several different ways. In certain embodiments, a rod may be formed with an optically transparent inner region along the length of the rod, an optically transparent outer region along the length of the rod, and a substantially optically non-transparent intermediate region along the length of the rod. the length of the rod between the inner region and the outer region. Cross-sectional sections along a plane substantially perpendicular to an axis parallel to the length of the rod may be cut to form an implant body (e.g., lens body) with a mask across the implant body. In certain embodiments, a rod may be formed by forming an optically transparent rod. An opaque cylinder may form around the optically transparent rod. An optically transparent cylinder can then be formed around the opaque cylinder. In certain embodiments, the cylinders are formed by casting or molding.

In alternative embodiments, an implant body may be formed and a mask may then be attached to the posterior surface and/or anterior surface of the implant body. For example, the mask may be adhesively adhered (e.g., glued), mechanically bonded, press fit, welded (e.g., bond welding, area welding), tape bonded, press fit, thermal fit, or pressure fit. swelling by hydration, holding by surface tension, electrical charge, magnetic attraction, polymerization, in situ cross-linking (e.g., radiation cross-linking), chemical means, etc. Figure 25A illustrates one embodiment of an intraocular implant 8000 with a mask 8002 coupled to the anterior surface of the implant body 8004, and Figure 25B illustrates another embodiment of an intraocular implant 8010 with a mask 8012 coupled to the posterior surface of the implant body. 8014 implant.

In certain embodiments, the implant body includes a structure to allow a mask to be securely attached thereto. For example, the implant body may include clips or other structures to physically attach the mask. The implant body may include a recessed portion on the posterior or anterior surface. A mask that substantially fills the recessed portion may be placed in the recessed portion of the implant body. The inner periphery and/or the outer periphery of the recessed portion may include one or more protuberances. The inner periphery and/or the outer periphery may include one or more recesses. The mask may be attached to the implant body by inserting the mask into the recessed portion and the one or more protuberances may enter the one or more recesses to prevent the mask from separating from the implant body. In certain embodiments, the mask is attached to the implant body after the intraocular implant has been inserted into the patient. In other embodiments, the mask is attached to the implant body before the implant body has been inserted into the patient. For example, the mask may be attached to the implant body in a factory or in an operating room.

According to the invention, an implant body is formed around a mask. The implant body is injected molded around a mask. Figure 25C illustrates an embodiment of an intraocular implant 8020 with a mask 8022 embedded within the implant body 8024. The mask 8032, 8042 may also be embedded near the anterior or posterior surface of the implant body 8034, 8044 of the intraocular implant 8030, 8040, as illustrated in Figures 25D and 25<e>, respectively. As illustrated in Figure 25<f>, the mask 8052 may also be positioned near the transition zone 8056 of the implant body 8054. When the mask is positioned on the surface of the transition zone or within close proximity of the surface of the transition zone, the mask need not necessarily extend beyond the transition zone 8056 since light even at large angles incident or passing through the surface of the transition zone would be blocked by the mask. The mask 8062 may also extend from the anterior surface to the posterior surface of the implant body 8064, as illustrated in Figure 25G. Any of the locations or positions of the masks of Figures 25A-G can be applied to any of the implant bodies and intraocular implants described herein. According to the invention, the mask is attached to a front surface of the optic.

In certain embodiments, the intraocular implant includes one or more support elements that extend from the mask to an outer surface of the implant body to assist in the manufacture of intraocular implants with masks. The support members may suspend the mask in a mold cavity in the desired alignment relative to the mold cavity. A contact portion of the support member may physically contact a wall of the mold cavity to support the mask. For example, the support members may be releasably attached to the mold to keep the mask stationary while the implant body is injected around the mask, but may be removed after the implant body has been formed. The support member may be mechanically attached to the mask, or the support member and mask may be a single piece (e.g., monolithic structure).

Figure 26A illustrates one embodiment of an intraocular implant 8100 with a mask 8104 that is within an implant body 8102. The intraocular implant 8100 includes one or more support elements 8106 that are coupled to the mask 8104 and extend at least as far as the outer periphery 8106 of the implant body 8102. The support elements 8106 may extend to the surface of the outer periphery 8106 or may extend beyond the surface of the outer periphery 8106.

Figure 26B illustrates a second example of an intraocular implant 8110 that includes support elements 8116. The support elements 8116 are coupled to the mask 8114 and extend from the mask 8814 to at least the rear surface 8113 of the implant body 8112. By positioning the support elements 8116 between the mask 8114 and the back surface 8113, the support elements 8816 can be hidden from a patient's line of sight.

Figure 26C illustrates another example of support members 8126 that are hidden from a patient's line of sight. The mask 8124 and the support elements 8126 are integrated into a toroid with a triangular or trapezoidal cross-sectional shape. The portion of the torus closest to the anterior surface of the implant body 8122 extends radially inward and outward more than the portion of the torus closest to the posterior surface of the implant body 8122. A cross section of the mask 8124 and the Support elements 8126 appear as a backward-pointing triangle or as an inverted pyramid. Advantageously, this embodiment minimizes unwanted light blocking.

The support structures may also include tabs that can be removed after the implant body has been formed around the mask. Figure 27A illustrates an embodiment of an intraocular implant 8200 with support structures 8202 that include flanges. The support structures 8202 have a first portion 8208 that extends from the mask 8204 to a position within the implant body 8206 with a first cross-sectional area. The support structures 8202 also have a second portion 8209 that extends from the first portion to the surface of the implant body 8206 with a second cross-sectional area that is greater than the first cross-sectional area. After the implant body 8206 is formed around the mask 8204, the support structures 8202 may be broken at or near the first portion 8208, as illustrated in Figure 27B. Removal of the second portion 8209 may leave a cavity 8207 in the implant body 8206. The cavity 8207 may be left open or may be filled. For example, if it is desired to increase the biocompatibility of the implant 8200, the cavities 8207 can be filled so that the mask 8204 is physically or biologically isolated from the eye within or by the implant body 8206.

Figure 28A is a top view and Figure 28B is a cross-sectional view of an embodiment of an intraocular implant 6700 with a support member 6702. The support member 6702 extends from the mask 6704 to the outer periphery 6706 of the body of implant 6708. The support member 6702 may include one or more contact portions 6710 that can be removably attached to the mold during injection of the implant body 6708 around the mask 6704. In certain embodiments, the implant body 6708 is injected around both the mask 6704 and the support member 6702. The support member 6702 may also include attachment elements 6712 that couple the contact portions 6710 and the mask 6704. The attachment elements 6712 have a front surface area and /or rear that is minimized so that the attachment element 6712 substantially does not block light passing through the implant body 6708 outside the outer periphery of the mask 6704.

The support structure 6702 may include more mass near the outer periphery of the implant body 6708 where the support structure 6702 would be less likely to interfere with the patient's vision. For example, the support structure 6702 may have a crown or ring near the outer periphery of the implant body 6708 that provides additional support and further restricts movement of the mask 6704 and portions of the support structure 6702 during the installation process. molding when the material flows around the mask. The flow of material can produce forces on the mask 6704 and the support structure 6702. In certain embodiments, the implant body 6708 and the haptics 6716 are a single piece (e.g., monolithic structure).

As illustrated in Figure 28A, the mask 6704, the attachment elements 6712 and/or the support structure 6702 may include light transmission structures 6720 such as holes, as described herein. The mask 6704 may also include an inner peripheral region 6722 adjacent to the inner diameter and an outer peripheral region 6724 adjacent to the outer diameter having substantially no light transmission structures 6720, as described above. The light transmission structures 6720 can be applied to any of the embodiments described herein and the different configurations of the light transmission structures described herein, such as variable hole spacing, size, shape and/or orientation They may apply to this embodiment or any embodiment that includes a mask.

Figure 29A is a top view and Figure 29B is a cross-sectional view of an embodiment of an intraocular implant 6800 similar to the intraocular implant 6700 of Figures 28A and 28B with a different optical power. The intraocular implant features described herein can be combined with a variety of optical power implant bodies.

Figure 30A is a top view and Figure 30B is a cross-sectional view of another embodiment of an intraocular implant 6900 similar to the intraocular implant 6700 of Figures 28A and 28B. The outer periphery of the mask 6904 extends beyond the outer periphery of the transition zone (e.g., second portion) 6914 which may block light passing through the transition zone 6914 at large incident angles (e.g. , angle between the normal to the surface and the incident light) to the anterior surface of the implant body 6908.

Figures 31A-34B are additional embodiments of intraocular implants 7000, 7100, 7200, 7300 with various configurations of support elements 7002, 7102, 7202, 7302. For example, the intraocular implants 7000, 7100 of Figures 31A-32B have elements of support 7002, 7102 having connecting elements 7012, 7112 that form a loop from a first portion of the mask 7004, 7104 to a contact portion 7010, 7110 and back to a second portion of the mask 7004, 7104. Intraocular implants 7200, 7300 of Figures 33A-34B are similar to intraocular implant 6700 of Figures 28A-B, however, the connecting elements 7212, 7312 do not connect the mask 7204, 7304 and the contact parts 7210, 7310 a through a straight path. The connecting elements 7212, 7312 connect the mask 7204, 7304 and the contact portions 7210, 7310 via a curved or wavy path. The curved or wavy path may reduce the visible effects of the attachment elements 7212, 7312 that a patient may observe.

The support elements can be integrated with the haptic of the intraocular implant. The haptic and the support element may be coupled together or may be a single piece (e.g., monolithic structure). In certain embodiments, the mask, the support element and the haptic are all coupled together. For example, the mask, the support element and the haptic may be a single piece (e.g., monolithic structure). The mask, the support element and/or the haptic may comprise the same material. Furthermore, the mask, the support element and/or the haptic may comprise the same material as the implant body; however, the mask, support element and/or haptic may include or incorporate a dye or other pigment to create opacity. Alternatively, the mask, the support element and/or the haptic may comprise different materials than the implant body, but may be materials that are compatible with the material of the implant body. Figure 35A is a top view and Figure 35B is a cross-sectional view of an embodiment of an intraocular implant 7400 with a support structure 7402 coupled to a mask 7404 and haptics 7416. The support structure 7402 extends away from the mask 7404 to an outer surface of the implant body 7408. The haptics 7416 extend away from the support structure 7402 and the implant body 7408. The haptics 7416 may provide mold contact portions to retain the mask 7404 while the body of implant 7408 is injected around the mask 7404. The mask 7404, the support structure 7402 and the haptics 7416 may be a single piece or coupled together so that they are configured to resist forces applied to the mask during formation of the implant body 7408. In certain embodiments, the haptic, support elements and mask may be substantially planar.

Figure 36A is a top view and Figure 36B is a cross-sectional view of an embodiment of an intraocular implant 7500 similar to the intraocular implant 7400 of Figures 35A-B. However, the mask 7504 is configured to be close to the anterior surface 7518 of the implant body 7508 and follows the contours of the anterior surface 7518 of the implant body 7508. The closer the mask 7504 is to the anterior surface 7518, the less light passing through the transition zone 7914 on the anterior surface at large incident angles may pass through the posterior surface 7520 which may be observed as artifacts visible to a patient. For embodiments where the transition zone is on the back surface, the mask can be positioned to be close to the back surface. The support member 7502 may also be configured to be close to the anterior surface 7518 of the implant body 7508.

In certain embodiments, the mask is printed on an implant body. The mask can be printed on the posterior and/or anterior surface of the implant body. The printed mask may be adjacent to the surface of the implant body or may penetrate the implant body (staining, tattooing, etc.). Printing options may include offset printing, block printing, jet printing, etc. The mask can also be applied to the implant body by thermal transfer or hot stamping. The mask may also be laser engraved on the surface or within the implant body, such as with subsurface laser engraving. The printed mask may be bonded or adhered to the implant body. In certain embodiments, the mask is printed on the implant body after the implant body has been inserted into the patient. In other embodiments, the mask is printed on the implant body before the implant body has been inserted into the patient. For example, the mask can be printed on the implant body in a factory or in an operating room.

Figures 37A-D illustrate another method of forming a mask 8308 on the anterior (or posterior) surface of an implant body 8300 with a transition zone 8304. Figure 37A illustrates an implant body 8300 without a transition zone 8304 or mask 8308. A cavity 8302 such as a crown may be formed (mechanically, chemically, etc.) on the anterior surface of the implant body 8300, as illustrated in Figure 37B. The cavity 8302 may form the transition zone 8304. As illustrated in Figure 37C, the cavity 8302 may be at least partially filled with an opaque material 8306 so that the transition zone 8304 is substantially covered. The central region 8310 may be formed (mechanically, chemically, etc.), as illustrated in Figure 37D. Part of the opaque material 8306 may also be removed when forming the central region 8310 while leaving a layer of opaque material 8306 substantially covering the transition zone 8304 to form a mask 8308.

Figures 38A-E illustrate the method of forming a mask 8408 within the implant body 8400. Figure 38A illustrates an implant body 8400. Figure 38B illustrates the implant body 8400 with a cavity 8402 formed in the anterior surface. A mask 8408 may be placed within the cavity 8402, as illustrated in Figure 38C, and the cavity 8402 may be at least partially filled with a material from the implant body 8406 to embed the mask 8408 in the implant body 8400, as shown. illustrated in Figure 38D. Figure 38E illustrates the implant body 8400 with a portion of the implant body material removed to form the central region 8410 and the transition zone 8404.

Figures 39A-D illustrate another method of forming a mask 8508 on the anterior surface of an implant body 8500 with a transition zone 8504. Figure 39A illustrates an implant body 8500 without a transition zone 8504 or mask 8508. A cavity 8502 such as a crown is formed on the anterior surface of the implant body 8500, as illustrated in Figure 39B. As illustrated in Figure 39C, the cavity 8502 may be at least partially filled with an opaque material 8506. The central region 8510 may be formed, as illustrated in Figure 39D. Part of the opaque material 8506 may also be removed when the central region 8510 is formed, and the opaque material 8506 may form a transition zone 8504 and a mask 8508.

In certain embodiments, a mask is formed in or on the implant body by selectively making the material of the implant body opaque or reflective. For example, materials such as black silicone, Teflon carbon powder, PVDF with carbon, etc. can be used. Additional examples of materials that the mask may include are described in US Patent Publication No. 2006/0265058. The implant body may be a material that changes from transparent to opaque (for example, a photochromic material) or reflective when exposed to certain conditions. The molecular structure of the implant body material can be changed optically, chemically, electrically, etc. For example, the structure of the implant body can be changed to create voids, altered index regions, surface facets, etc. In certain embodiments, a dye in or on the implant body can be activated with light or electricity to change from being transparent to opaque or reflective. In certain embodiments, the mask is formed after the implant body has been inserted into the patient. In other embodiments, the mask is formed before the implant body has been inserted into the patient. For example, the mask can be formed in a factory or in an operating room.

In certain embodiments, the implant body has posterior and/or anterior surfaces with contours to create optical power. The contours of the implant body surfaces can also be formed by various methods. For example, the implant body can be molded to a shape. In another example, the surfaces of the implant body can be milled to form contours.

The haptics may be formed with the implant body or may be subsequently attached to the implant body. For example, the haptics can be cast or molded onto the implant body in a one-piece configuration. Additionally, the haptics can be mechanically attached to the implant body. For example, holes can be drilled in the implant body and haptics can be inserted. Haptics can also be attached using an adhesive or glue. In certain embodiments, the intraocular implant does not have an implant body. If the intraocular implant does not have an implant body, the haptics can be attached to the mask.

There are also several methods for positioning and fitting the mask within a mold cavity of a mold. For example, a single mold may be used while the position of a mask within the mold cavity may be adjusted to precisely position the mask with respect to the mold cavity and ultimately the implant body. Figure 40 illustrates an embodiment of a mask positioning system 9000 that includes positioning sensors 9010, a mask positioning apparatus 9020, and a control system 9030. The control system 9030 may include the sensor interface 9032 in electrical communication. with a feedback control 9034 that is in electrical communication with a mask positioning interface 9036. The mask positioning apparatus 9020 may position the mask 9040 within the implant body 9050.

The 9010 positioning sensors can be used to measure the position of the mask within the mold cavity. For example, a Hall effect sensor can detect magnetic fields, and the sensor's output voltage can vary in response to changes in a magnetic field. With a fixed magnetic field, the distance to the source of the field can be accurately calculated. Diamagnetic levitation and induction levitation are options that can be used with a magnetic mask. Cameras, ultrasonic detectors, capacitive proximity sensors, and laser interferometry can also be used to measure the position of the mask.

Various types of mask positioning apparatus 9020 and methods can be used to move and position the mask within the mold cavity. For example, wires, such as nanowires, may be attached to the mask and to a frame such as a frame surrounding the mask. Figure 41 illustrates an embodiment of a mask positioning apparatus 9100 that includes four nanowires 9102 that are coupled to four areas on the mask 9104 at positions at 0, 90, 180, and 270 degrees on the mask 9104 to a surrounding frame 9106. The frame 9106 can then be moved to position the mask 9104 with, for example, mechanical actuators and/or servos 9108. The nanowires can be formed by electrodeposition. In certain embodiments, the mask and nanowires are electrodeposited to form a monolithic structure. Since the mask may have a low mass, small wires such as nanowires could be sufficient to move the mask within a liquid polymer, and could easily be broken or cut from the implant body after the polymer has solidified or cured. An advantage of nanowires is that they are small and would minimize the optical performance of the intraocular implant. In certain embodiments, the wires themselves may also provide movement of the mask, thus eliminating the use of external actuators. The wires could include a shape memory alloy such as nitinol that, when heated, can deform to cause movement of the mask. Nitinol wires can be, for example, about 0.0762 mm (0.003 inch) in diameter (one inch is 25.4 mm)

Diamagnetic levitation can also be used to position the mask. A diamagnetic substance is one whose atoms do not have a permanent magnetic dipole moment. When an external magnetic field is applied to a diamagnetic substance, a weak magnetic dipole moment is induced in the direction opposite to the applied field. Pyrolytic graphite is strongly diamagnetic, and pyrolytic graphite has a specific gravity of about 2.1, so it levitates easily. Diamagnetic levitation occurs by bringing a diamagnetic material into close proximity to the material that produces a magnetic field. The diamagnetic material will repel the material that produces the magnetic field. Most substances that are not magnetic are weakly diamagnetic. The force of repulsion may not be strong enough to overcome the force of gravity. To cause diamagnetic levitation, both the diamagnetic material and the magnetic material produce a combined repulsive force to overcome the force of gravity. The magnetic field can be from a permanent magnet or it can be from an electromagnet. The mask 9202 may be a diamagnetic material that can be levitated with a magnetic field 9204, as illustrated in Figure 42. The magnetic field may be manipulated to position the mask within a mold cavity. For example, the magnetic field can be set to restrain the mask while also levitating it. Multiple magnetic fields (e.g., magnets) can be used to control the properties and shape of the magnetic field. Figures 43A and 43B illustrate top views of examples of first magnetic fields 9302, 9308 and second magnetic fields 9304, 9310 that can constrain a mask 9306, 9312. The first magnetic fields 9302, 9308 have a magnetic field opposite to the second magnetic fields 9304, 9310. In certain embodiments, the mask includes a permanent magnetic field. If the mask has a permanent magnetic field, more force can occur between the mask and the magnetic fields.

A mask can also be levitated using sonic levitation. An acoustic radiation pressure can produce an intense sound wave in the liquid polymer to move the mask. Electrostatic levitation can also be used by applying an electrostatic field to the mask to counteract gravity. The high voltage electrodes 9402 may be oriented around the mask 9404, as illustrated in Figure 44. For example, two electrodes 9402 may be oriented on opposite sides of the mask 9404 in each of three axes that are perpendicular to each other to a total of six electrodes. The electrodes may be in electrical communication with a high voltage generator and a 9406 controller.

The mask may be formed by a bistable display (e.g., cholesteric liquid crystal display (ChLCD)) that is capable of maintaining a state (e.g., opaque or transparent) without electrical power. Figure 45 illustrates a bistable display 9502. Electrical energy can be used to change the state of a pixel 9504 to either opaque or transparent. Pixels that are opaque can form the mask. Therefore, the inner diameter, outer diameter, and opening of the mask can be adjusted.

VII. Intraocular implants with haptics

Anterior chamber intraocular lenses have generally been made of poly(methyl methacrylate) (PMMA), which is a relatively hard thermoplastic. It was believed that a certain amount of rigidity was necessary to maintain implant stability in the anterior chamber. For example, you can add a reinforcing element to the haptic to achieve desirable stability of the intraocular lens (see, for example, US Patent No. 6,228,115 (Hoffmann, et al.)). However, the forces of compression of PMMA intraocular lenses are much higher than those required for stability. It is also possible to construct intraocular lenses from soft materials such as silicones, hydrogels, and soft acrylic compounds. With these softer materials, there is some question regarding the stability of the implant in the anterior chamber; However, intraocular implants made of soft material are stable when certain compression forces and contact areas are used.

For example, the commercially available Bausch & Lomb NuVita model MA 20 exhibits a force response of approximately 2.7 mN at 1 mm of compression when measured according to the industry's conventional compression test, ISO/DIS 11979-3. The intraocular implant illustrated in Figures 46-47 may exhibit a force response of less than about 0.5 mN at 1 mm of compression when made of a soft acrylic material, which is similar to the Alcon model SA30EL posterior chamber lens. commercially available. The large haptic contact areas found in posterior chamber IOLs, such as the Alcon SA30EL model, are generally not suitable for anterior chamber implantation because such designs can cause translational movement of the haptic contact points. in relation to the tissue of the anterior chamber, resulting in chronic irritation and the formation of synechiae. Callus formation around the haptics can also lead to late-onset glaucoma. Advantageously, an intraocular implant having haptics that contact the anterior chamber angle in only four locations, and with a haptic extension ratio to optic diameter of less than 1.5, and preferably about 1 .3 for a 5.5mm optic provides sufficient stability without excessive angular contact.

As illustrated in Figures 46 and 47, an intraocular implant 5010 may include an intraocular body 5014 with a mask 5020 in or on the implant body 5014. The implant body 5014 may include a lens body. For example, the lens body may include any lens body described herein. Additionally, the 5010 intraocular implant can be implanted in phakic or aphakic patients.

In certain embodiments, the intraocular implant 5010 includes a mask 5020 embedded in or supported by a single piece comprising a soft acrylic compound, such as those described in US Patent Nos. 5,290,892, 5,403,901, 5433746, 5,674. 960, 5,861,031 and 5,693,095. Such a material allows the intraocular implant 5010 to be rolled or folded to pass through a surgical incision of 3.5 mm or less and be implanted in the anterior chamber of an eye. The 5010 intraocular implant may also be made of a soft silicone or hydrogel material. In certain embodiments, the intraocular implant 5010 includes two opposing pairs of foot plates 5012 joined to the implant body 5014 by haptics 5016 and ramps 5018. The implant body 5014 can have any suitable diameter, but preferably is between 5.0 mm and 6.0mm The footplates 5012 are separated by the haptic 5016 by a distance S, which is preferably less than 1.5 times the diameter of the implant body 5014, and most preferably about 1.3 times the diameter of the implant body 5014. The foot plates 5012 and haptics 5016 are preferably between 0.20 and 0.30 mm thick, which provides sufficient compressive force, while minimizing axial doming of the intraocular implant 5010 to less than 1.5 mm. and preferably less than 1.0 mm when the footplates 5012 and haptics 5016 are compressed by 1 mm. As discussed above, the compressive force of the haptics 5016 and foot plates 5012 may be sufficient for the stability of the intraocular implant 5010, but not so great as to cause irritation or ovalization of the pupil. Preferably, the intraocular implant 5010 exhibits a force response of approximately less than 0.5 mN, and more preferably, less than approximately 0.3 mN, when the intraocular implant 5010 is compressed 1 mm according to the conventional industrial test ISO/ DIS 11979-3.

The mask 5020 has an aperture 5022 to improve the depth of focus of a human eye. In certain embodiments, the opening 5022 is a small hole opening. The mask 5020 may extend across the entire anteroposterior dimension of the implant body 5014, as illustrated in Figure 48A. Preferably, the mask will be no more than about 85% or 95% of the anteroposterior thickness of the finished lens, such that the lens body material overlaps and encapsulates the mask to provide a continuous outer surface.

The implant of Figure 46, and other implants described below can be manufactured by lamination, or other techniques known in the art. For example, the mask may be placed in a mold cavity followed by the introduction of a monomer, polymer, or other lens precursor material that is changed from a fluid state to a solid state to encapsulate the mask.

The mask 5021, 5023 may be located on, adjacent to, near or adjacent to the anterior or posterior surface of the implant body 5011, 5013, as illustrated in Figures 48B and 48C, respectively. In certain embodiments, the mask is separated from the surfaces of the implant body. For example, the mask 5025 may be located substantially in a central portion 5024, for example, midway between the posterior and anterior surfaces of the implant body 5015, as illustrated in Figure 48D. In certain embodiments, the mask 5027 is located between the central portion 5024 and the rear surface of the implant body 5017, as illustrated in Figure 48E. Certain embodiments include the mask 5027 which is located halfway, one third or two thirds between the central portion 5024 and the rear surface of the implant body 5017. In certain other embodiments, the mask 5029 is located between the central portion 5024 and the anterior surface of the implant body 5019, as illustrated in Figure 48F. Certain embodiments include the mask 5029 which is located midway, one-third, or two-thirds between the central portion 5024 and the anterior surface of the implant body 5019.

VIII. Intraocular implants with masks

Intraocular implants to improve a patient's vision, such as by increasing the depth of focus of a patient's eye, may include different types of structures. Figures 49A-C illustrate one embodiment of the intraocular implant 6000 with an implant body 6002. The implant body 6002 may include a mask 6006, an opening 6008 surrounded by the mask 6006, and an outer hole region 6010 around the mask 6006. The outer hole region 6010 may have an outer portion 6012 of the implant body 6002 around it.

The intraocular implant 6000 may include one or more haptics 6004 to prevent the intraocular implant 6000 from moving or rotating within the eye. The haptics 6004 can have a variety of shapes and sizes depending on the location in which the intraocular implant 6000 is implanted in the eye. For example, haptics 6004 illustrated in Figures 49A-C and haptics 6104 illustrated in Figures 50A-C have different haptics. The haptics 6004, 6104 illustrated in Figures 49-50 are generally suitable for intraocular implants fixed in the sulcus 6000, 6100; However, the intraocular implants 6000, 6100 can be interchanged with any variety of haptics (e.g., haptics described above), and can be implanted in any suitable location within the eye (e.g., anterior chamber and posterior chamber).

As illustrated in Figures 49A and 49B, the outer hole region 6010 includes five outer holes 6014 that form a ring around the opening 6008. The outer hole region 6010 may include one or more connection portions 6016. The Connection 6016 may be between at least two of the outer holes 6015. The connection portion 6016 connects or joins the mask 6006 and the outer portion 6012 of the implant body 6002. In certain embodiments, the mask 6006, the connection portions 6016 and The outer portion 6012 are a single integrated piece. In certain embodiments, the single integrated part also includes haptics 6004. The outer holes 6014 may be formed in the single integrated part by stamping, cutting, burning, etching, etc.

In certain embodiments, at least a portion of the implant body is opaque. As used herein, the term “opaque” is intended to indicate a transmission of no more than approximately 2% of the incident visible light. In one embodiment, at least a portion of the implant body 6002 is configured to be opaque to greater than 99% of the light incident thereon. In certain embodiments, at least a portion of the mask 6006 is opaque. In certain other embodiments, at least a portion of the mask 6006 is configured to transmit between 2 and 5% of the incident visible light. In certain embodiments, the mask 6006 transmits no more than 95% of the incident visible light. In certain embodiments, the intraocular implant 6000 is a single integrated opaque piece.

The size of the aperture 6008 may be any size that is effective in increasing the depth of focus of an eye of a patient suffering from presbyopia. For example, the opening 6008 may be circular. In one embodiment, the opening 6008 has a diameter of less than about 2 mm. In another embodiment, the diameter of the opening is between about 1.6 mm and about 2.0 mm. In another embodiment, the opening 6008 has a diameter of approximately 1.6 mm or less. In another embodiment the diameter of the opening is approximately 1.4 mm. In certain embodiments, the diameter of the opening is between about 0.85 mm and about 2.2 mm. In further embodiments, the diameter of the opening is between about 1.1 mm and about 1.7 mm.

In certain embodiments, the outer orifice region 6010 of the intraocular implant 6000 may improve low light vision. As the pupil of the eye enlarges, eventually light rays will enter and pass through the outer orifice region 6010 of the intraocular implant 6000. If the pupil of the eye is large enough for the light rays to pass through Through the outer hole region 6010 of the intraocular implant 6000, additional light rays will impinge on the retina.

The outer hole region 6010 can have a variety of shapes and sizes. Figures 51-54 illustrate various embodiments of intraocular implants. Figures 51A-E illustrate intraocular implants similar to the intraocular implant 6000 of Figures 49A-C, except that the number of connection portions 6016 connecting the mask 6006 with the outer portion 6012 of the implant body 6002 and the number of outer holes 6014 vary. Figures 51A, 51B, 51C, 51D and 51E illustrate the intraocular implants 6200a, 6200b, 6200c, 6200d, 6200e with a connection portion 6216a and an outer hole 6214a in the outer hole region 6010a, with two connection portions 6216b and two outer holes 6214b in the outer hole region 6010b, with three connection portions 6216c and three outer holes 6214c in the outer hole region 6010c, with four connection portions 6216d and four outer holes 6214d in the outer hole region 6010d and with six connecting portions 6216e and six outer holes 6214e in the outer hole region 6010e, respectively.

Intraocular implants 6000 may have any number of connection portions 6016. Embodiments include intraocular implants with at least one connection portion, at least two connection portions, at least three connection portions, at least four connection portions, at least five connecting portions, at least six connecting portions, less than ten connecting portions, less than six connecting portions, between one and ten connecting portions.

Similarly, intraocular implants 6000 may have any number of exterior holes 6014. Embodiments include intraocular implants with at least one exterior hole, with at least two exterior holes, with at least three exterior holes, with at least four exterior holes, at least five exterior holes, at least six exterior holes, less than ten exterior holes, less than six exterior region holes, between one and ten exterior region holes.

In certain embodiments, the cross-sectional area perpendicular to the length of an outer hole of at least one outer hole is at least about 1 mm2. In certain embodiments, the cross-sectional area perpendicular to the length of the outer holes of at least two outer holes is at least approximately 1 mm2 for each of the at least two outer holes. In certain embodiments, the area on the implant body of the outer hole region is at least about 5 mm2 or at least about 10 mm2.

The distance between the outer perimeter 6018 of the opening 6008 (e.g., the inner perimeter 6018 of the mask 6006) and the outer perimeter 6020 of the mask 6006 may also vary. For example, the distance between the outer perimeter 6018 of the aperture 6008 and the outer perimeter 6020 of the mask 6006 can be adjusted depending on the particular patient and the location within the eye in which the intraocular implant 6000 is located. Embodiments include the distance between the outer perimeter 6018 of the opening 6008 and the outer perimeter 6020 of the mask 6006 to be about 1.1 mm, between about 0.8 and about 1.4 mm, between about 0.4 and about 2.5 mm, greater than zero, greater than approximately 0.4 mm and greater than approximately 0.8 mm.

In certain embodiments, the aperture 6008 and/or the outer hole region 6010 includes optical power and refractive properties. For example. The aperture 6008 and/or the outer hole region 6010 may include an optic and may have an optical power (e.g., positive or negative optical power). In certain embodiments, the aperture 6008 and/or the outer hole region 6010 may correct refractive errors of an eye.

The distance between the inner perimeter 6020 of the outer hole region 6010 (e.g., the outer perimeter 6020 of the mask 6006) and the outer perimeter 6022 of the outer hole region 6010 can be a variety of sizes. Embodiments include the distance between the inner perimeter 6020 of the outer hole region 6010 and the outer perimeter 6022 of the outer hole region 6010 to be about 0.85 mm, greater than about 0.7 mm, greater than about 0.4 mm, greater than zero, between about 0.6 and about 1.0 mm and between about 0.2 and about 1.5 mm. Figure 52 illustrates an embodiment of an intraocular implant 6300 where the outer perimeter 6322 of the outer hole region 6310 extends to near the outer perimeter 6324 of the implant body 6302. For example, the distance between the outer perimeter 6322 of the region of outer hole 6310 and the outer perimeter 6324 of the implant body 6302 may be less than 0.5 mm or less than 0.1 mm.

In certain embodiments, the outer hole region 6010 has an incident visible light transmission of at least 90% or at least 95%. In certain embodiments, the area of the outer hole region 6010 includes at least 90% or at least 95% of outer holes 6014. In certain embodiments, the area of the outer hole region 6010 includes no more than 10% or no more than 5% of 6016 connection portions.

The outer hole region 6010 may have irregular annular shapes. Figures 53A-C illustrate examples of variations in annular shapes. As illustrated in Figure 53A, the outer hole region 6410a has outer holes 6414a of different sizes. The distance between the inner perimeter 6420a of the outer hole region 6410a and the outer perimeter 6422a of the outer hole region 6410a may vary annularly around the outer hole region 6410a. The distance between the outer perimeter 6422a of the outer hole region 6410a and the outer perimeter 6424a of the implant body 6402a may also vary annularly around the outer hole region 6410a.

In certain embodiments, the connecting portions 6016 extend substantially radially from the center of the implant body 6002, as illustrated in Figure 49B. Figure 53B illustrates an embodiment in which the connecting portions 6416b do not extend radially from the center of the implant body 6402b. For example, the lengths of the connecting portions 6416b may be substantially parallel.

In certain embodiments, the outer hole region 6010 is substantially shaped like an annular circle, as illustrated in Figures 49-51. As illustrated in Figure 53C, the outer hole region 6410c may have a substantially annular square shape. In certain embodiments, the outer hole region 6410c is shaped like an annular polygon.

In certain embodiments, the outer hole region 6010 may be a substantially continuous ring, as illustrated in Figures 49-53. As illustrated in Figure 54, the outer hole region 6500 may have a partial annular shape. In certain embodiments, the outer hole region 6010 at least partially surrounds the mask 6506 and/or the opening 6508.

In certain embodiments, the opening 6008 is substantially centered on the mask 6006, as illustrated in Figures 49-53. The opening 6608, 6708 may also be offset in the mask 6606, 6706, as illustrated in Figures 55 and 56. Figure 55 illustrates an embodiment with the opening 6608 substantially centered in the implant body 6602 with the hole region outside 6610 offset in the implant body 6602 (e.g., the outer hole region 6610 closer to one edge of the implant body 6602 than an opposite edge of the implant body 6602). Figure 56 illustrates an embodiment with the outer hole region 6710 substantially centered on the implant body 6702 with the opening 6708 offset within the outer hole region 6710. The opening 6008 may be substantially circular or of any shape as described above .

The intraocular implant 6000 can have a variety of thicknesses (e.g., distance between the posterior and anterior surfaces). For example, the thickness of the intraocular implant 6000 may be about 0.2 mm, less than about 0.5 mm, less than about 0.3 mm, or less than about 0.2 mm.

The outer holes 6014 may be open holes or may be filled with a substantially transparent material. For example, outer holes 6014 may be formed in the implant body 6002 and a substantially transparent material may be used to fill the outer holes 6014.

The mask 6006 of the intraocular implant 6000 may be any of the variations described above. In certain embodiments, the mask 6006 includes light transmission holes. For example, the configuration of the mask 4000 illustrated in Figure 24A may be a configuration of a mask 6806 used in an intraocular implant 6800, as illustrated in Figure 57.

Figure 58 illustrates another embodiment of an intraocular implant 6900 with a mask region 6930 with light transmission holes 6932. In certain embodiments, the intraocular implant 6900 is opaque in at least one region. For example, mask region 6930 may be opaque. The light transmission holes 6932 may vary in size, density (e.g., number of holes per unit area), and/or surface area (e.g., percentage of the surface area of the light transmission holes 6932 compared to the total surface area of the mask region 6930) in one or more portions of the mask region 6930. For example, the size, density and/or surface area of the light transmission holes 6932 may increase or decrease radially from the inner periphery 6918 of the mask region 6930 to the outer periphery 6924 of the implant body 6902. The transition in size and/or density of the light transmission holes 6932 may be gradual or one or more steps. As illustrated in the embodiment of Figure 58, the size of the light transmission holes 6932 gradually increases in size radially outward from the opening 6908 while the number of light transmission holes per unit area decreases. In certain embodiments, the light transmission holes 6932 are irregularly spaced or have an irregular pattern.

Various embodiments have been described above. Although the invention has been described with reference to these specific embodiments, the descriptions are intended to be illustrative and are not intended to be limiting. Various modifications and applications may occur to those skilled in the art without departing from the scope of the invention as defined in the appended claims.

Claims (6)

1. A method for manufacturing an intraocular implant (100) comprising: placing an opaque mask in a mold chamber, the opaque mask comprising an outer diameter in the range of from 3 mm to 8 mm and an opening with a diameter of less than 2 mm; flowing a lens material in the mold chamber around the mask; and cure the lens material to form a single vision optic, wherein, upon curing the lens material, the opaque mask is coupled to an anterior surface of the single vision optic, the annular mask having an annular portion with a relatively low visible light transmission surrounding a central portion of relatively high transmission to that passes light through the retina to increase the depth of focus, in use. 2. The method according to claim 1, further comprising manufacturing the opaque mask before providing the opaque mask to the mold chamber. 3. The method according to claim 1, wherein the opaque mask comprises a mask material that is the same as the lens material. 4. The method according to claim 1, wherein the mask material comprises an acrylic copolymer. 5. The method according to claim 1, further comprising forming the opaque mask with a curvature that corresponds to a contour of the anterior surface of the optic. 6. The method according to claim 1, wherein the opaque mask (108) further comprises a dye or other pigment to create opacity.